Clinical trial NCT02879305: Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
Official title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anaemia
Aspergillosis, Allergic Bronchopulmonary
Keywords: erythropoiesis stimulating agents
GSK1278863
daprodustat
anemia
chronic kidney disease
hemoglobin
recombinant human erythropoietin
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-08-25
Enrollment: 2964
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.


Eligibility criteria: Inclusion Criteria:

* Age: 18 to 99 years of age (inclusive).
* Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
* Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose. Hgb \>11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
* Dialysis: On dialysis \>90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
* Frequency of Dialysis: Hemodialysis (HD) \>=2 times/week and peritoneal dialysis (PD) \>=5 times/week. Home hemodialysis \>=2 times/week.
* Compliance with placebo \[randomization (Day 1) only\]: \>=80% and \<=120% compliance with placebo during run-in period.
* Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion Criteria:

* Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
* Ferritin: \<=100 nanograms (ng)/milliliter (mL) (\<=100 micrograms/liter \[L\]) at screening.
* Transferrin saturation (TSAT) (screening only): \<=20%.
* Aplasias: History of bone marrow aplasia or pure red cell aplasia.
* Other causes of anemia: Untreated Pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
* Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding \<=4 weeks prior to screening through to randomization (Day 1).
* MI or acute coronary syndrome: \<=4 weeks prior to screening through to randomization (Day 1).
* Stroke or transient ischemic attack: \<=4 weeks prior to screening through to randomization (Day 1).
* Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
* Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of recombinant human erythropoietin (rhEPO).
* Bazett's corrected QT interval (QTcB) (Day 1): QTcB \>500 millisecond (msec), or QTcB \>530 msec in subjects with bundle branch block. There is no QT Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
* Alanine transaminase (ALT): \>2x upper limit of normal (ULN) at screening.
* Bilirubin: \>1.5xULN at screening.
* Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example \[e.g.\] Bosniak Category II F, III or IV) \> 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated \>=4 weeks prior to screening.
* Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or epoetin alfa or darbepoetin alfa.
* Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
* Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1).
* Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of \>30 days.
* Females only: Subject is pregnant \[as confirmed by a positive serum human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options listed in the List of Highly Effective Methods for Avoiding Pregnancy.
* Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.

Primary outcomes:
measure: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Mean Change From Baseline in Hemoglobin (Hgb) Levels During Evaluation Period (Week 28 to Week 52)
timeFrame: Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)
Secondary outcomes:
measure: Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period: Superiority Analysis
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Mean Average Monthly On-treatment IV Iron Dose Per Participant
timeFrame: Day 1 to Week 52
measure: Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period
timeFrame: Up to 3.9 person-years for vital status follow-up time period
measure: Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis)
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period
timeFrame: Up to 3.9 person-years for CV follow-up time period
measure: Change From Baseline in Post-randomization Hemoglobin Levels at Week 52
timeFrame: Baseline (Pre-dose on Day 1) and Week 52
measure: Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)
timeFrame: Week 28 to Week 52
measure: Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis
timeFrame: Week 28 to Week 52
measure: Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis
timeFrame: Week 28 to Week 52
measure: Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis
timeFrame: Week 28 to end of study (3.9 person-years for follow-up time period)
measure: Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis
timeFrame: Week 28 to end of study (3.9 person-years for follow-up time period)
measure: Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52
timeFrame: Baseline (Week -4) and Week 52
measure: Change From Baseline in SBP, DBP, MAP at End of Treatment
timeFrame: Baseline (Week -4) and 45.1 months
measure: Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years
timeFrame: Day 1 to end of study (3.9 person-years for follow-up time period)
measure: Number of Participants With at Least One BP Exacerbation Event During Study
timeFrame: Day 1 to end of study (3.9 person-years for follow-up time period)
measure: Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria
timeFrame: Day 1 to 45.1 months
measure: Change From Baseline in On-Treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52
timeFrame: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
measure: Change From Baseline in On-Treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
timeFrame: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
measure: Change From Baseline in On-Treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52
timeFrame: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
measure: Change From Baseline in On-Treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
timeFrame: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
measure: Change From Baseline in On-Treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52
timeFrame: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
measure: Change From Baseline in On-Treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52
timeFrame: Baseline (Pre-dose on Day 1) and Week 52
measure: Change From Baseline in On-Treatment EuroQol Visual Analogue Scale (EQ-VAS) at Week 52
timeFrame: Baseline (Pre-dose on Day 1) and Week 52
measure: Change From Baseline in On-Treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52
timeFrame: Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Pine Bluff
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Beverly Hills
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facility: GSK Investigational Site
state: California
city: Cerritos
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facility: GSK Investigational Site
state: California
city: Chula Vista
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facility: GSK Investigational Site
state: California
city: El Centro
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facility: GSK Investigational Site
state: California
city: Escondido
country: United States
facility: GSK Investigational Site
state: California
city: Fairfield
country: United States
facility: GSK Investigational Site
state: California
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Glendale
country: United States
facility: GSK Investigational Site
state: California
city: Granada Hills
country: United States
facility: GSK Investigational Site
state: California
city: Hacienda Heights
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facility: GSK Investigational Site
state: California
city: La Mesa
country: United States
facility: GSK Investigational Site
state: California
city: La Palma
country: United States
facility: GSK Investigational Site
state: California
city: Lakewood
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Lynwood
country: United States
facility: GSK Investigational Site
state: California
city: Montebello
country: United States
facility: GSK Investigational Site
state: California
city: Monterey Park
country: United States
facility: GSK Investigational Site
state: California
city: Moreno Valley
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facility: GSK Investigational Site
state: California
city: Norco
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facility: GSK Investigational Site
state: California
city: Northridge
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facility: GSK Investigational Site
state: California
city: Ontario
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state: California
city: Riverside
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facility: GSK Investigational Site
state: California
city: Sacramento
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facility: GSK Investigational Site
state: California
city: San Diego
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facility: GSK Investigational Site
state: California
city: San Diego
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state: California
city: San Luis Obispo
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state: California
city: Santa Clarita
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state: California
city: Simi Valley
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state: California
city: Tarzana
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facility: GSK Investigational Site
state: California
city: Whittier
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facility: GSK Investigational Site
state: California
city: Whittier
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facility: GSK Investigational Site
state: California
city: Yorba Linda
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facility: GSK Investigational Site
state: California
city: Middlebury
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facility: GSK Investigational Site
state: Connecticut
city: Washington
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facility: GSK Investigational Site
state: District of Columbia
city: Aventura
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facility: GSK Investigational Site
state: Florida
city: Coral Gables
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facility: GSK Investigational Site
state: Florida
city: Hollywood
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facility: GSK Investigational Site
state: Florida
city: Jacksonville
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facility: GSK Investigational Site
state: Florida
city: Lauderdale Lakes
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facility: GSK Investigational Site
state: Florida
city: Miami Gardens
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facility: GSK Investigational Site
state: Florida
city: Miami
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facility: GSK Investigational Site
state: Florida
city: Miami
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facility: GSK Investigational Site
state: Florida
city: Miami
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state: Florida
city: Miami
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state: Florida
city: Winter Park
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state: Florida
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state: Georgia
city: Augusta
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state: Georgia
city: Columbus
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state: Georgia
city: Meridian
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state: Idaho
city: Crystal Lake
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state: Illinois
city: Fort Wayne
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state: Indiana
city: Jeffersonville
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facility: GSK Investigational Site
state: Indiana
city: Merrillville
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state: Indiana
city: Michigan City
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state: Indiana
city: Iowa City
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facility: GSK Investigational Site
state: Iowa
city: Louisville
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facility: GSK Investigational Site
state: Kentucky
city: Baton Rouge
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facility: GSK Investigational Site
state: Louisiana
city: Baton Rouge
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facility: GSK Investigational Site
state: Louisiana
city: Greenbelt
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facility: GSK Investigational Site
state: Maryland
city: Takoma Park
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facility: GSK Investigational Site
state: Maryland
city: Kalamazoo
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facility: GSK Investigational Site
state: Michigan
city: Pontiac
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facility: GSK Investigational Site
state: Michigan
city: Roseville
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facility: GSK Investigational Site
state: Michigan
city: Gulfport
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facility: GSK Investigational Site
state: Mississippi
city: Tupelo
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facility: GSK Investigational Site
state: Mississippi
city: Florissant
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facility: GSK Investigational Site
state: Missouri
city: Kansas City
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facility: GSK Investigational Site
state: Missouri
city: Saint Louis
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facility: GSK Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Las Vegas
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facility: GSK Investigational Site
state: Nevada
city: Portsmouth
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facility: GSK Investigational Site
state: New Hampshire
city: Gallup
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facility: GSK Investigational Site
state: New Mexico
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facility: GSK Investigational Site
state: New York
city: Brooklyn
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facility: GSK Investigational Site
state: New York
city: Buffalo
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facility: GSK Investigational Site
state: New York
city: Flushing
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state: New York
city: Mineola
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facility: GSK Investigational Site
state: New York
city: New York
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facility: GSK Investigational Site
state: New York
city: Ridgewood
country: United States
facility: GSK Investigational Site
state: New York
city: Yonkers
country: United States
facility: GSK Investigational Site
state: New York
city: Asheville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Clyde
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Roseburg
country: United States
facility: GSK Investigational Site
state: Oregon
city: Bethlehem
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Anderson
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Charleston
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facility: GSK Investigational Site
state: South Carolina
city: Sumter
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Cordova
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
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facility: GSK Investigational Site
state: Texas
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facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
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facility: GSK Investigational Site
state: Texas
city: San Antonio
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facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Alexandria
country: United States
facility: GSK Investigational Site
state: Virginia
city: Fairfax
country: United States
facility: GSK Investigational Site
state: Virginia
city: Hampton
country: United States
facility: GSK Investigational Site
state: Virginia
city: Salem
country: United States
facility: GSK Investigational Site
state: Virginia
city: Bluefield
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Shorewood
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Burzaco
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Evita
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Pergamino
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Pilar
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Córdoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Formosa
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: Moron
country: Argentina
facility: GSK Investigational Site
city: San Miguel de Tucumán
country: Argentina
facility: GSK Investigational Site
city: Concord
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kingswood
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kogarah
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Liverpool
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Birtinya
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Herston
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Woolloongabba
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: St Albans
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Murdoch
country: Australia
facility: GSK Investigational Site
city: Graz
country: Austria
facility: GSK Investigational Site
city: St. Pölten
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Baudour
country: Belgium
facility: GSK Investigational Site
city: Brugge
country: Belgium
facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Hasselt
country: Belgium
facility: GSK Investigational Site
city: Ieper
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Roeselare
country: Belgium
facility: GSK Investigational Site
city: Salvador
country: Brazil
facility: GSK Investigational Site
state: Bahia
city: Curitiba
country: Brazil
facility: GSK Investigational Site
state: Paraná
city: Curitiba
country: Brazil
facility: GSK Investigational Site
state: Paraná
city: Passo Fundo
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: GSK Investigational Site
state: Santa Catarina
city: Sao Jose do Rio Preto
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Belo Horizonte, Minas Gerais
country: Brazil
facility: GSK Investigational Site
city: Feira de Santana
country: Brazil
facility: GSK Investigational Site
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
city: Sao Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
city: Blagoevgrad
country: Bulgaria
facility: GSK Investigational Site
city: Dobrich
country: Bulgaria
facility: GSK Investigational Site
city: Gabrovo
country: Bulgaria
facility: GSK Investigational Site
city: Lom
country: Bulgaria
facility: GSK Investigational Site
city: Lovech
country: Bulgaria
facility: GSK Investigational Site
city: Montana
country: Bulgaria
facility: GSK Investigational Site
city: Pazardzhik
country: Bulgaria
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Ruse
country: Bulgaria
facility: GSK Investigational Site
city: Smolyan
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: GSK Investigational Site
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Beroun
country: Czechia
facility: GSK Investigational Site
city: Frýdek-mistek
country: Czechia
facility: GSK Investigational Site
city: Ivancice
country: Czechia
facility: GSK Investigational Site
city: Jilemnice
country: Czechia
facility: GSK Investigational Site
city: Marianske Lazne
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Praha 2
country: Czechia
facility: GSK Investigational Site
city: Praha 4
country: Czechia
facility: GSK Investigational Site
city: Praha 4
country: Czechia
facility: GSK Investigational Site
city: Sokolov
country: Czechia
facility: GSK Investigational Site
city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Holstebro
country: Denmark
facility: GSK Investigational Site
city: Kolding
country: Denmark
facility: GSK Investigational Site
city: Odense C
country: Denmark
facility: GSK Investigational Site
city: Svendborg
country: Denmark
facility: GSK Investigational Site
city: Parnu
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Annonay
country: France
facility: GSK Investigational Site
city: Bois-Guillaume
country: France
facility: GSK Investigational Site
city: Bordeaux
country: France
facility: GSK Investigational Site
city: Boulogne Billancourt
country: France
facility: GSK Investigational Site
city: Caen Cedex 9
country: France
facility: GSK Investigational Site
city: Mulhouse
country: France
facility: GSK Investigational Site
city: Poitiers
country: France
facility: GSK Investigational Site
city: Reims
country: France
facility: GSK Investigational Site
city: Tours cedex 9
country: France
facility: GSK Investigational Site
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bad Koenig
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Cloppenburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kaiserslautern
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Dieburg
country: Germany
facility: GSK Investigational Site
city: Freiburg
country: Germany
facility: GSK Investigational Site
city: Minden
country: Germany
facility: GSK Investigational Site
city: Alexandroupolis
country: Greece
facility: GSK Investigational Site
city: Arta
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion-Crete
country: Greece
facility: GSK Investigational Site
city: Ioannina
country: Greece
facility: GSK Investigational Site
city: Ioannina
country: Greece
facility: GSK Investigational Site
city: Komotini
country: Greece
facility: GSK Investigational Site
city: Larissa
country: Greece
facility: GSK Investigational Site
city: Patras
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Egri
country: Hungary
facility: GSK Investigational Site
city: Esztergom
country: Hungary
facility: GSK Investigational Site
city: Kecskemet
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Pécs
country: Hungary
facility: GSK Investigational Site
city: Pécs
country: Hungary
facility: GSK Investigational Site
city: Szigetvar
country: Hungary
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Calicut
country: India
facility: GSK Investigational Site
city: Chennai, Tamil Nadu
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Delhi
country: India
facility: GSK Investigational Site
city: Gurgaon
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Mumbai
country: India
facility: GSK Investigational Site
city: Nadiad
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: New Delhi
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Secunderabad
country: India
facility: GSK Investigational Site
city: Trivandrum
country: India
facility: GSK Investigational Site
city: Catanzaro
country: Italy
facility: GSK Investigational Site
state: Calabria
city: Reggio Calabria
country: Italy
facility: GSK Investigational Site
state: Calabria
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Piacenza
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Bergamo
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Lecco
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Monza
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pavia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Seriate
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Foggia
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Cagliari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Imola
country: Italy
facility: GSK Investigational Site
city: Mestre
country: Italy
facility: GSK Investigational Site
city: Anyang-Si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon-si,
country: Korea, Republic of
facility: GSK Investigational Site
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon
country: Korea, Republic of
facility: GSK Investigational Site
city: Uijeongbu-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Wonju-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Batu Caves
country: Malaysia
facility: GSK Investigational Site
city: Ipoh
country: Malaysia
facility: GSK Investigational Site
city: Johor Bahru
country: Malaysia
facility: GSK Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Pahang
country: Malaysia
facility: GSK Investigational Site
city: Penang
country: Malaysia
facility: GSK Investigational Site
city: Saltillo
country: Mexico
facility: GSK Investigational Site
state: Coahuila
city: Durango.
country: Mexico
facility: GSK Investigational Site
state: Durango
city: Ciudad De México
country: Mexico
facility: GSK Investigational Site
state: Estado De México
city: Cuautitlan Izcalli
country: Mexico
facility: GSK Investigational Site
state: Estado De México
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Queretaro
country: Mexico
facility: GSK Investigational Site
state: Querétaro
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
city: Aguascalientes
country: Mexico
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: México, D.F.
country: Mexico
facility: GSK Investigational Site
city: Zapopan, Jalisco
country: Mexico
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Deventer
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Hastings
country: New Zealand
facility: GSK Investigational Site
city: Otahuhu
country: New Zealand
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Biala Podlaska
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Grojec
country: Poland
facility: GSK Investigational Site
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Kolobrzeg
country: Poland
facility: GSK Investigational Site
city: Kolo
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Olkusz
country: Poland
facility: GSK Investigational Site
city: Pruszkow
country: Poland
facility: GSK Investigational Site
city: Tomaszow Mazowiecki
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Zary
country: Poland
facility: GSK Investigational Site
city: Amadora
country: Portugal
facility: GSK Investigational Site
city: Corroios.
country: Portugal
facility: GSK Investigational Site
city: Covilhã
country: Portugal
facility: GSK Investigational Site
city: Forte Da Casa
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Mirandela
country: Portugal
facility: GSK Investigational Site
city: Portimão
country: Portugal
facility: GSK Investigational Site
city: Vila Franca de Xira
country: Portugal
facility: GSK Investigational Site
city: Vila Real (Lordelo)
country: Portugal
facility: GSK Investigational Site
city: Arad
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Resita
country: Romania
facility: GSK Investigational Site
city: Targu-Jiu
country: Romania
facility: GSK Investigational Site
city: Irkutsk
country: Russian Federation
facility: GSK Investigational Site
city: Krasnodar
country: Russian Federation
facility: GSK Investigational Site
city: Mytischi
country: Russian Federation
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Omsk
country: Russian Federation
facility: GSK Investigational Site
city: Orenburg
country: Russian Federation
facility: GSK Investigational Site
city: Penza
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Volzhsky
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Cape Town.
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Majadahonda
country: Spain
facility: GSK Investigational Site
state: Madrid
city: Alcala de Henares
country: Spain
facility: GSK Investigational Site
city: Aranda de Duero
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Ciudad Real
country: Spain
facility: GSK Investigational Site
city: Girona
country: Spain
facility: GSK Investigational Site
city: Guadalajara
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Manises (Valencia)
country: Spain
facility: GSK Investigational Site
city: Mollet del Valles
country: Spain
facility: GSK Investigational Site
city: Málaga
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Sabadell
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Keelung
country: Taiwan
facility: GSK Investigational Site
city: New Taipei City
country: Taiwan
facility: GSK Investigational Site
city: New Taipei City
country: Taiwan
facility: GSK Investigational Site
city: New Taipei
country: Taiwan
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan Hsien
country: Taiwan
facility: GSK Investigational Site
city: Zhongzheng Dist., Taipei
country: Taiwan
facility: GSK Investigational Site
city: Adana
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Antalya
country: Turkey
facility: GSK Investigational Site
city: Edirne
country: Turkey
facility: GSK Investigational Site
city: Eskisehir
country: Turkey
facility: GSK Investigational Site
city: Kayseri
country: Turkey
facility: GSK Investigational Site
city: Chernihiv
country: Ukraine
facility: GSK Investigational Site
city: Chernivtsi
country: Ukraine
facility: GSK Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: GSK Investigational Site
city: Kherson
country: Ukraine
facility: GSK Investigational Site
city: Kiev
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Mykolaiv
country: Ukraine
facility: GSK Investigational Site
city: Ternopil
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: GSK Investigational Site
city: Zhytomyr
country: Ukraine
facility: GSK Investigational Site
city: Stevenage
country: United Kingdom
facility: GSK Investigational Site
state: Hertfordshire
city: Preston
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Wolverhampton
country: United Kingdom
facility: GSK Investigational Site
state: West Midlands
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Derby
country: United Kingdom
facility: GSK Investigational Site
city: Doncaster
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: Fife
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
citation: Singh AK, Carroll K, Perkovic V, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Blackorby A, Cizman B, Cobitz AR, Davies R, Dole J, Kler L, Meadowcroft AM, Zhu X, McMurray JJV; ASCEND-D Study Group. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2325-2335. doi: 10.1056/NEJMoa2113379. Epub 2021 Nov 5.
citation: Singh AK, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Perkovic V, Solomon S, Wanner C, Waikar SS, Wheeler DC, Wiecek A. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant. 2022 Apr 25;37(5):960-972. doi: 10.1093/ndt/gfab065.