Clinical trial NCT02876835: Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
Official title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anaemia
Keywords: GSK1278863
hemoglobin
anemia
non-dialysis
erythropoiesis stimulating agents
daprodustat
chronic kidney disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 3872
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 non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.


Eligibility criteria: Inclusion Criteria:

* Age: 18 to 99 years of age (inclusive)
* CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.
* Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and no ESA use between screening and randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks prior to screening and continuing between screening and randomization.
* For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to 10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8 should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.
* \>=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.

Exclusion Criteria:

* Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 90 days after study start (Day 1).
* 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.
* 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 Q-T 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 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). At screening, this exclusion applies to use of the investigational agent within 30 days or within five half lives (whichever is longer).
* Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of \>30 days.
* Females only: Subject is pregnant \[as confirmed by a positive urine human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options.
* 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 darbepoetin alfa) 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 4.3 person-years for CV follow-up time period
measure: Mean Change From Baseline in Hgb Levels Over the 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 4.3 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 4.3 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 4.3 person-years for CV follow-up time period
measure: Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period
timeFrame: Up to 4.3 person-years for CV follow-up time period
measure: Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period
timeFrame: Up to 4.3 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 4.3 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 4.3 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 4.3 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 4.3 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 4.3 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 4.3 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 4.3 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 4.3 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 4.3 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 4.3 person-years for CV follow-up time period
measure: Time to First Occurrence of Confirmed 40% Decline in eGFR During CV Events Follow-up Time Period
timeFrame: Up to 4.3 person-years for CV follow-up time period
measure: Time to First Occurrence of Chronic Dialysis During CV Events Follow-up Time Period
timeFrame: Up to 4.3 person-years for CV follow-up time period
measure: Time to First Occurrence of Kidney Transplant During CV Events Follow-up Time Period
timeFrame: Up to 4.3 person-years for CV follow-up time period
measure: Change From Baseline in Post-randomization Hgb 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 Hgb 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 Hgb 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 Hgb 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 (4.3 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 (4.3 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 51.1 months
measure: Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years
timeFrame: Day 1 to end of treatment (51.1 months)
measure: Number of Participants With at Least One BP Exacerbation Event During Study
timeFrame: Day 1 to end of treatment (51.1 months)
measure: Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria
timeFrame: Day 1 to 51.1 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 EQ 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 Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52
timeFrame: Baseline (Day 1) and Weeks 8, 12, 28, 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
measure: Change From Baseline in Post-randomization Estimated Glomerular Filtration Rate (eGFR) at Week 52
timeFrame: Baseline (Pre-dose on Day 1) and Week 52
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
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state: Alabama
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state: Arizona
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state: Arizona
city: Phoenix
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state: California
city: Bakersfield
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facility: GSK Investigational Site
state: California
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state: California
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state: California
city: Escondido
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state: California
city: Glendale
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state: California
city: Granada Hills
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state: California
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state: California
city: Long Beach
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city: Los Angeles
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city: Los Angeles
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state: California
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state: Georgia
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state: Georgia
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state: Georgia
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state: Idaho
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state: Illinois
city: Chicago
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state: Illinois
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state: Indiana
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city: Houston
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facility: GSK Investigational Site
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state: Texas
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state: Texas
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facility: GSK Investigational Site
state: Texas
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facility: GSK Investigational Site
state: Texas
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country: United States
facility: GSK Investigational Site
state: Virginia
city: Fairfax
country: United States
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state: Virginia
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country: United States
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state: Virginia
city: Salem
country: United States
facility: GSK Investigational Site
state: Virginia
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country: United States
facility: GSK Investigational Site
state: West Virginia
city: Ciudad Evita
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Coronel Suarez
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
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country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Pergamino
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
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country: Argentina
facility: GSK Investigational Site
state: Córdova
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country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
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city: Buenos Aires
country: Argentina
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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: Garran
country: Australia
facility: GSK Investigational Site
state: Australian Capital Territory
city: Concord
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Gosford
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: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Nambour
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Reservoir
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: Liverpool
country: Australia
facility: GSK Investigational Site
city: Aalst
country: Belgium
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: 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: Ronse
country: Belgium
facility: GSK Investigational Site
city: Sint-Niklaas
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: 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: Porto Alegre
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: Sao Jose do Rio Preto
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Votuporanga
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Belo Horizonte
country: Brazil
facility: GSK Investigational Site
city: Brasilia
country: Brazil
facility: GSK Investigational Site
city: Feira de Santana
country: Brazil
facility: GSK Investigational Site
city: Joinville
country: Brazil
facility: GSK Investigational Site
city: Juiz De Fora
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: Burgas
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: Pazardzhik
country: Bulgaria
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Sliven
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: Stara Zagora
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: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Barranquilla
country: Colombia
facility: GSK Investigational Site
city: Bogotá
country: Colombia
facility: GSK Investigational Site
city: Cali
country: Colombia
facility: GSK Investigational Site
city: Floridablanca
country: Colombia
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: Beroun
country: Czechia
facility: GSK Investigational Site
city: Cesky Krumlov
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: Novy Jicin
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: 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: Jämejala Village
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: Boulogne Billancourt
country: France
facility: GSK Investigational Site
city: Caen Cedex 9
country: France
facility: GSK Investigational Site
city: Clermont-Ferrand
country: France
facility: GSK Investigational Site
city: Lyon
country: France
facility: GSK Investigational Site
city: Montpellier
country: France
facility: GSK Investigational Site
city: Mulhouse
country: France
facility: GSK Investigational Site
city: Poitiers
country: France
facility: GSK Investigational Site
city: Saint-Ouen
country: France
facility: GSK Investigational Site
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Cloppenburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kaiserslautern
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Koeln
country: Germany
facility: GSK Investigational Site
city: Wiesbaden
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: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Efkarpia
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: Melissia
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: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Lai Chi kok
country: Hong Kong
facility: GSK Investigational Site
city: New Territories
country: Hong Kong
facility: GSK Investigational Site
city: Tsuen Wan
country: Hong Kong
facility: GSK Investigational Site
city: Baja
country: Hungary
facility: GSK Investigational Site
city: Balatonfured
country: Hungary
facility: GSK Investigational Site
city: Esztergom
country: Hungary
facility: GSK Investigational Site
city: Kecskemét
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Pecs
country: Hungary
facility: GSK Investigational Site
city: Salgótarján
country: Hungary
facility: GSK Investigational Site
city: Szigetvar
country: Hungary
facility: GSK Investigational Site
city: Ahmedabad
country: India
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: Chandigarh
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: Ghaziabad
country: India
facility: GSK Investigational Site
city: Gurgaon
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Lucknow
country: India
facility: GSK Investigational Site
city: Manipal
country: India
facility: GSK Investigational Site
city: Mumbai
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: 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: Ashkelon
country: Israel
facility: GSK Investigational Site
city: Hadera
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Nahariya
country: Israel
facility: GSK Investigational Site
city: Nazareth
country: Israel
facility: GSK Investigational Site
city: Poriya
country: Israel
facility: GSK Investigational Site
city: Zerifin
country: Israel
facility: GSK Investigational Site
city: Catanzaro
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: Reggio Emilia
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Lecco
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Pavia
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
country: Korea, Republic of
facility: GSK Investigational Site
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Ilsanseo-gu, Goyang-si,
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam
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: 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: 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: Alor Setar
country: Malaysia
facility: GSK Investigational Site
city: Ipoh
country: Malaysia
facility: GSK Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Kuantan
country: Malaysia
facility: GSK Investigational Site
city: Lumut
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: Torreon
country: Mexico
facility: GSK Investigational Site
state: Coahuila
city: Durango.
country: Mexico
facility: GSK Investigational Site
state: Durango
city: Ciudad De Mexico
country: Mexico
facility: GSK Investigational Site
state: Estado De México
city: Leon
country: Mexico
facility: GSK Investigational Site
state: Guanajuato
city: León
country: Mexico
facility: GSK Investigational Site
state: Guanajuato
city: Guadalajara.
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Queretaro
country: Mexico
facility: GSK Investigational Site
state: Querétaro
city: Culiacan
country: Mexico
facility: GSK Investigational Site
state: Sinaloa
city: Culiacan
country: Mexico
facility: GSK Investigational Site
state: Sinaloa
city: Mazatlán
country: Mexico
facility: GSK Investigational Site
state: Sinaloa
city: Merida
country: Mexico
facility: GSK Investigational Site
state: Yucatán
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: Ciudad De México
country: Mexico
facility: GSK Investigational Site
city: Ciudad De México
country: Mexico
facility: GSK Investigational Site
city: Culiacan
country: Mexico
facility: GSK Investigational Site
city: Tlalnepantla De Baz
country: Mexico
facility: GSK Investigational Site
city: Veracruz
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: Dunedin
country: New Zealand
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: Takapuna, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Baguio City, Benguet
country: Philippines
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Dasmarinas
country: Philippines
facility: GSK Investigational Site
city: Iloilo City
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Pasig
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: San Juan
country: Philippines
facility: GSK Investigational Site
city: Sto Tomas
country: Philippines
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Brzeg
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Kolobrzeg
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Radom
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Zyrardow
country: Poland
facility: GSK Investigational Site
city: Amadora
country: Portugal
facility: GSK Investigational Site
city: Aveiro
country: Portugal
facility: GSK Investigational Site
city: Covilhã
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: Torres Novas
country: Portugal
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucuresti
country: Romania
facility: GSK Investigational Site
city: Constanta
country: Romania
facility: GSK Investigational Site
city: Oradea
country: Romania
facility: GSK Investigational Site
city: Timisoara
country: Romania
facility: GSK Investigational Site
city: Irkutsk
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Krasnodar
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Mytischi
country: Russian Federation
facility: GSK Investigational Site
city: Omsk
country: Russian Federation
facility: GSK Investigational Site
city: Podolsk
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
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: Ulyanovsk
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: Singapore
country: Singapore
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Cape Town.
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Majadahonda
country: Spain
facility: GSK Investigational Site
state: Madrid
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: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Burela
country: Spain
facility: GSK Investigational Site
city: Caceres
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: L'Hospitalet de Llobregat
country: Spain
facility: GSK Investigational Site
city: Mollet del Valles
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: 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
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: 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: Bangkoknoi
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiang Mai
country: Thailand
facility: GSK Investigational Site
city: Khon Kaen
country: Thailand
facility: GSK Investigational Site
city: Pathumthani
country: Thailand
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: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Kayseri
country: Turkey
facility: GSK Investigational Site
city: Cherkasy
country: Ukraine
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: Kharkiv
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: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lutsk
country: Ukraine
facility: GSK Investigational Site
city: Mykolaiv
country: Ukraine
facility: GSK Investigational Site
city: Poltava
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: Hampstead
country: United Kingdom
facility: GSK Investigational Site
state: London
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Wolverhampton
country: United Kingdom
facility: GSK Investigational Site
state: West Midlands
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
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: 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: Leeds
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: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Middlesbrough
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
city: York
country: United Kingdom
facility: GSK Investigational Site
city: Ha Noi City
country: Vietnam
facility: GSK Investigational Site
city: Ha Noi
country: Vietnam
facility: GSK Investigational Site
city: Hai Phong
country: Vietnam
facility: GSK Investigational Site
city: Hanoi
country: Vietnam
facility: GSK Investigational Site
city: Ho Chi Minh City
country: Vietnam
facility: GSK Investigational Site
city: Ho Chi Minh
country: Vietnam
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ajay K. Singh, Kevin Carroll, John J. V. McMurray, Scott Solomon, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Lata Kler, Amy M. Meadowcroft, Lin Taft, Vlado Perkovic for the ASCEND-ND Study Group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS NOT UNDERGOING DIALYSIS. N Engl J Med. 2021; DOI: 10.1056/NEJMoa2113380 PMID: 34739196
citation: Perkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.
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, McMurray JJV, 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, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2313-2324. doi: 10.1056/NEJMoa2113380. Epub 2021 Nov 5.