Clinical trial NCT02021318: Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
Official title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia in Chronic Kidney Disease in Non-dialysis Patients
Keywords: Non-dialysis
Roxadustat
ASP1517
Chronic Kidney Disease (CKD)
Anemia
Hemoglobin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: FibroGen
First posted: 2013-12-27
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.

Detailed description: This was a phase 3, multicenter, randomized, open-label, active-controlled study. The study was planned to provide key efficacy and safety data for the approval of roxadustat in the treatment of anemia associated with CKD. Participants assigned to roxadustat treatment were administered roxadustat orally as a combination of tablets of different strengths. Participants assigned to darbepoetin alfa treatment were administered darbepoetin alfa subcutaneously or intravenously.

The study consisted of 3 study periods:

* Screening period: up to 6 weeks
* Treatment period: 104 weeks
* Follow-up period: 4 weeks until planned study end (end of year 2)

Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of CKD, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not on dialysis; with an Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m\^2 estimated using the abbreviated 4-variable Modification of Diet in Renal Disease (MDRD) equation.
* The mean of the subject's two most recent (prior to randomization) Hb values during the screening period, obtained at least 4 days apart, must be less than or equal to 10.5 g/dL, with a difference of less than or equal to 1.0 g/dL. The last Hb value must be within 10 days prior to randomization.
* Subject is deemed suitable for treatment with Erythropoiesis Stimulating Agent (ESA) using the criteria specified in the Kidney Disease Improving Global Outcomes (KDIGO) 2012 recommendation considering the rate of fall of Hb concentration, prior response to iron therapy, the risk of needing a transfusion, the risks related to ESA therapy and the presence of symptoms attributable to anemia.
* Subject has a serum folate level greater than or equal to lower limit of normal (LLN) at screening.
* Subject has a serum vitamin B12 level greater than or equal to LLN at screening.
* Subject's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than or equal to 3 x upper limit of normal (ULN), and total bilirubin (TBL) is less than or equal to 1.5 x ULN.
* Subject's body weight is 45.0 kg to a maximum of 160.0 kg.
* Male subject must not donate sperm starting from screening, throughout the study period and up to 12 weeks after final study drug administration.

Exclusion Criteria:

* Subject has received any Erythropoiesis Stimulating Agent (ESA) treatment within 12 weeks prior to randomization.
* Subject has received any dose of IV iron within 6 weeks prior to randomization.
* Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization.
* Subject has a known history of myelodysplastic syndrome or multiple myeloma.
* Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD).
* Subject has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.
* Subject has a known chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.
* Subject is anticipated to undergo elective surgery that is expected to lead to significant blood loss during the study period or anticipated elective coronary revascularization.
* Subject has active or chronic gastrointestinal bleeding.
* Subject has received any prior treatment with roxadustat or a Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
* Subject has been treated with iron-chelating agents within 4 weeks prior to randomization.
* Subject has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver).
* Subject has known New York Heart Association Class III or IV congestive heart failure.
* Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
* Subject has one or more contraindications for treatment with darbepoetin alfa:

  * Uncontrolled hypertension, or two or more blood pressure values of SBP greater than or equal to 160 mmHg or DBP greater than or equal to 95 mmHg (within 2 weeks prior to randomization).
  * Known hypersensitivity to darbepoetin alfa, recombinant human erythropoietin, or any of the excipients.
* Subject has a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category 2F or higher) of renal cell carcinoma as shown on renal ultrasound within 12 weeks prior to randomization.
* Subject has a history of malignancy, except for the following: cancers determined to be cured or in remission for greater than or equal to 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
* Subject is positive for any of the following:

  * human immunodeficiency virus (HIV).
  * hepatitis B surface antigen (HBsAg).
  * or anti-hepatitis C virus antibody (anti-HCV Ab).
* Subject has an active clinically significant infection that is manifested by White Blood Count (WBC) \> Upper Limit of Normal (ULN), and/or fever, in conjunction with clinical signs or symptoms of infection within one week prior to randomization.
* Subject has a known untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration or retinal vein occlusion.
* Subject has had any prior organ transplant (that has not been explanted), subject is scheduled for organ transplantation, or subject is likely to initiate renal replacement therapy including dialysis within the first year of the study.
* Subject will be excluded from participation if any of the following apply:

  * subject has received investigational therapy within 30 days or 5 half lives or limit set by national law, whichever is longer, prior to initiation of screening, or
  * any condition which makes the subject unsuitable for study participation.
* Subject has an anticipated use of dapsone in any dose amount or chronic use of acetaminophen/paracetamol \>2.0 g/day during the treatment or follow-up period of the study.
* Subject has a history of alcohol or drug abuse within 2 years prior to randomization

Primary outcomes:
measure: Percentage of Participants With a Hb Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Change From Baseline in Hb to the Average Hb of Weeks 28 to 36 Without Rescue Therapy Within 6 Weeks Prior to and During This 8-Week Evaluation Period
timeFrame: Baseline and weeks 28 to 36
measure: Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) to the Average LDL-C of Weeks 12 to 28
timeFrame: Baseline and weeks 12 to 28
measure: Time to First Intravenous Iron Use
timeFrame: Weeks 6, 12, 18, 24, 30 and 36
measure: Change From Baseline in Short Form-36 (SF-36) Physical Functioning (PF) Sub-Score to the Average PF Sub Score in Weeks 12 to 28
timeFrame: Baseline and weeks 12 to 28
measure: Change From Baseline in SF-36 Vitality (VT) Sub-Score to the Average VT Sub-Score in Weeks 12 to 28
timeFrame: Baseline and weeks 12 to 28
measure: Change From Baseline in Mean Arterial Pressure (MAP) to the Average MAP Value in Weeks 20 to 28: Per Protocol Set
timeFrame: Baseline and weeks 20 to 28
measure: Time to First Occurrence of Hypertension During Weeks 1 to 36: Per Protocol Set
timeFrame: Weeks 1 to 36
measure: Change From Baseline in MAP to the Average MAP Value in Weeks 20 to 28: Full Analysis Set
timeFrame: Baseline and weeks 20 to 28
measure: Time to First Occurrence of Hypertension During Weeks 1 to 36: Full Analysis Set
timeFrame: Weeks 1 to 36
measure: Change From Baseline in Hb to the Average Hb Value of Weeks 28 to 52 Regardless of Rescue Therapy
timeFrame: Baseline and weeks 28 to 52
measure: Time to First Hb Response During First 24 Weeks of Treatment Regardless of Administration of Rescue Therapy
timeFrame: Weeks 1 to 24
measure: Time to First Hb Response During First 24 Weeks of Treatment Without Rescue Therapy
timeFrame: Weeks 1 to 24
measure: Hb Level Averaged Over Weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104 Without Rescue Therapy
timeFrame: Weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104
measure: Change From Baseline in Hb to Each Postdosing Time Point Regardless Use of Rescue Therapy
timeFrame: Baseline and weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100 and 104
measure: Change From Baseline in Hb to Average Hb Value of Weeks 28 to 36, 44 to 52, 72 to 80, 96 to 104 Regardless of Use of Rescue Therapy
timeFrame: Baseline and weeks 28 to 36, 44 to 52, 72 to 80 and 96 to 104
measure: Percentage of Hb Values >=10 g/dL and Within 10.0 to 12.0 g/dL in Weeks 28 to 36, 44 to 52, and 96 to 104 Without Use of Rescue Therapy
timeFrame: Weeks 28 to 36, 44 to 52 and 96 to 104
measure: Time to First Hb Rate of Rise > 2 g/dL Within 4 Weeks
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Number of Hospitalizations
timeFrame: Baseline to EOT (up to week 104)
measure: Number of Days of Hospitalization Per Year
timeFrame: Baseline to EOT (up to week 104)
measure: Time to First Hospitalization
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Time to First Use of RBC Transfusion
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Number of RBC Packs
timeFrame: Baseline to EOT (up to week 104)
measure: Volume of RBC Transfused
timeFrame: Baseline to EOT (up to week 104)
measure: Number of Particpants Who Received RBC Transfusions
timeFrame: Baseline to EOT (up to week 104)
measure: Time to First Use of Rescue Therapy
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Number of Participants Who Received Rescue Therapy (Composite of RBC Transfusions (All Participants) and Darbepoetin Alfa Use (Roxadustat Treated Participants Only)
timeFrame: Baseline to EOT (up to week 104)
measure: Mean Monthly Intravenous Iron Per Participant During Weeks 37 to 52 and 53 to 104
timeFrame: Weeks 37 to 52 and 53 to 104
measure: Time to First Use of IV Iron Supplementation
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Percentage of Participants With Oral Iron Use Only
timeFrame: Day 1 to week 36, weeks 37 to 52, weeks 53 to 104, efficacy emergent period (up to week 104)
measure: Change From Baseline to Weeks 8, 28, 52 and 104 in Total Cholesterol
timeFrame: Baseline and weeks 8, 28, 52, 104
measure: Change From Baseline to Weeks 8, 28, 52 and 104 in LDL-C/High-Density Lipoprotein Cholesterol (HDL-C) Ratio
timeFrame: Baseline and weeks 8, 28, 52, 104
measure: Change From Baseline to Weeks 8, 28, 52 and 104 in Non-HDL Cholesterol
timeFrame: Baseline and weeks 8, 28, 52, 104
measure: Change From Baseline to Weeks 8, 28, 52 and 104 in Apolipoproteins A1 (ApoA1)
timeFrame: Baseline and weeks 8, 28, 52, 104
measure: Change From Baseline to Weeks 8, 28, 52 and 104 in Apolipoproteins B (ApoB)
timeFrame: Baseline and weeks 8, 28, 52, 104
measure: Change From Baseline to Weeks 8, 28, 52 and 104 in ApoB/ApoA1 Ratio
timeFrame: Baseline and weeks 8, 28, 52, 104
measure: Number of Participants With Mean LDL Cholesterol < 100 mg/dL
timeFrame: Weeks 12 to 28 and 36 to 52
measure: Number of Participants Who Had Achieved Antihypertensive Treatment Goal
timeFrame: Weeks 12 to 28 and 36 to 52
measure: Change From Baseline to the Average of Weeks 12 to 28 and 36 to 52 in SF-36 Physical Component Score (PCS)
timeFrame: Baseline, weeks 12 to 28 and 36 to 52
measure: Change From Baseline to the Average of Weeks 12 to 28 and 36 to 52 in Anemia Subscale (AnS) (Additional Concerns) of Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score
timeFrame: Baseline, weeks 12 to 28 and 36 to 52
measure: Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in FACT-An Total Score
timeFrame: Baseline, weeks 12 to 28 and 36 to 52
measure: Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in FACT-An Trial Outcome Index (TOI) Score
timeFrame: Baseline, weeks 12 to 28 and 36 to 52
measure: Change From Baseline to the Average Value of Weeks 12 to 28 in Euroqol Questionnaire-5 Dimensions 5 Levels (EQ-5D 5L) Visual Analogue Scale (VAS) Score
timeFrame: Baseline and weeks 12 to 28
measure: Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in Work Productivity and Activity Impairment-Anemic Symptoms (WPAI:ANS) Score: Percent Work Time Missed
timeFrame: Baseline, weeks 12 to 28 and 36 to 52
measure: Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Impairment While Working
timeFrame: Baseline, weeks 12 to 28 and 36 to 52
measure: Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Overall Work Impairment
timeFrame: Baseline, weeks 12 to 28 and 36 to 52
measure: Change From Baseline to the Average Value of Weeks 12 to 28 and 36 to 52 in WPAI:ANS Score: Percent Activity Impairment
timeFrame: Baseline, weeks 12 to 28 and 36 to 52
measure: Percentage of Participants With Improvements Measured by Patients' Global Impression of Change (PGIC)
timeFrame: Weeks 8, 12, 28, 52, 76, 104, last assessment (week 108)
measure: Change From Baseline to Each Scheduled Measurement in Serum Ferritin
timeFrame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and end of study (EOS) (up to 108 weeks)
measure: Change From Baseline to Each Scheduled Measurement in Transferrin Saturation (TSAT)
timeFrame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104 and EOS (up to 108 weeks)
measure: Change From Baseline to Each Scheduled Measurement in Glycated Hemoglobin (HbA1c)
timeFrame: Baseline and weeks 12, 28, 36, 44, 60, 84, 104 and EOS (up to 108 weeks)
measure: Change From Baseline to Each Scheduled Measurement in Fasting Blood Glucose
timeFrame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, 106 and EOS (up to 108 weeks)
measure: Change From Baseline to Each Scheduled Measurement in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline and weeks 4, 8, 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104, 106 and EOS (up to 108 weeks)
measure: Rate of Progression of Chronic Kidney Disease Measured by eGFR Slope Over Time
timeFrame: Baseline up to EOS (up to week 108)
measure: Change From Baseline to Each Scheduled Measurement in Urine Albumin/Creatinine Ratio (UACR)
timeFrame: Baseline and weeks 12, 24, 36, 52, 64, 76, 88 and 104
measure: Time to Doubling of Serum Creatinine or Chronic Dialysis or Renal Transplant Compared to Baseline
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Number of Participants With End Stage Renal Disease (ESRD)
timeFrame: Baseline up to EOS (up to week 108)
measure: Time to Chronic Kidney Disease Progression (Composite of Doubling Serum Creatinine, Chronic Dialysis or Renal Transplant, and Death)
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Time to Chronic Dialysis or Renal Transplant or Death
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Time to at Least 40% Decrease in eGFR From Baseline, Chronic Dialysis or Renal Transplant
timeFrame: Year 0.5, 1, 1.5 and 2
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to end of study (up to week 108)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Site AT43009
city: Brest
country: Belarus
facility: Site BY37503
city: Grodno
country: Belarus
facility: Site BY37501
city: Minsk
country: Belarus
facility: Site BY37506
city: Minsk
country: Belarus
facility: Site BY37507
city: Minsk
country: Belarus
facility: Site BY37505
city: Vitebsk
country: Belarus
facility: Site BY37502
city: Sofia
country: Bulgaria
facility: Site BG35907
city: Sofia
country: Bulgaria
facility: Site BG35927
city: Varna
country: Bulgaria
facility: Site BG35916
city: Karlovac
country: Croatia
facility: Site HR38505
city: Slavonski Brod
country: Croatia
facility: Site HR38504
city: Zagreb
country: Croatia
facility: Site HR38510
city: Zagreb
country: Croatia
facility: Site HR38502
city: Zagreb
country: Croatia
facility: Site HR38509
city: Novy Jicin
country: Czechia
facility: Site CZ42018
state: CZ
city: Liberec
country: Czechia
facility: Site CZ42008
city: Prague
country: Czechia
facility: Site CZ42021
city: Helsinki
country: Finland
facility: Site FI35810
city: Avignon
country: France
facility: Site FR33004
city: Colmar
country: France
facility: Site FR33009
city: Grenoble
country: France
facility: Site FR33010
city: Limoges
country: France
facility: Site FR33062
city: Lyon
country: France
facility: Site FR33012
city: Saint-Priest-en-Jarez
country: France
facility: Site FR33007
city: Tbilisi
country: Georgia
facility: Site GE99503
city: Tbilisi
country: Georgia
facility: Site GE99504
city: Tbilisi
country: Georgia
facility: Site GE99502
city: Cloppenburg
country: Germany
facility: Site DE49073
city: Düsseldorf
country: Germany
facility: Site DE49054
city: Hamburg
country: Germany
facility: Site DE49065
city: Heilbronn
country: Germany
facility: Site DE49075
city: Hoyerswerda
country: Germany
facility: Site DE49057
city: Budapest
country: Hungary
facility: Site HU36028
city: Budapest
country: Hungary
facility: Site HU36029
city: Kistarcsa
country: Hungary
facility: Site HU36027
city: Pecs
country: Hungary
facility: Site HU36008
city: Velence
country: Hungary
facility: Site HU36046
city: Cork
country: Ireland
facility: Site IE35301
city: Be'er Ya'akov
country: Israel
facility: Site IL97202
city: Haifa
country: Israel
facility: Site IL97215
city: Riga
country: Latvia
facility: Site LV37101
city: Ventspils
country: Latvia
facility: Site LV37104
city: Niksic
country: Montenegro
facility: Site ME38202
city: Podgorica
country: Montenegro
facility: Site ME38201
city: Utrecht
country: Netherlands
facility: Site NL31005
city: Skopje
country: North Macedonia
facility: Site MK38901
city: Struga
country: North Macedonia
facility: Site MK38903
city: Krakow
country: Poland
facility: Site PL48001
city: Pulawy
country: Poland
facility: Site PL48066
city: Szczecin
country: Poland
facility: Site PL48013
city: Tarnow
country: Poland
facility: Site PL48007
city: Warszawa
country: Poland
facility: Site PL48004
city: Wroclaw
country: Poland
facility: Site PL48009
city: Zamosc
country: Poland
facility: Site PL48059
city: Almada
country: Portugal
facility: Site PT35120
city: Braga
country: Portugal
facility: Site PT35131
city: Carnaxide
country: Portugal
facility: Site PT35112
city: Evora
country: Portugal
facility: Site PT35119
city: Lisboa
country: Portugal
facility: Site PT35118
city: Matosinhos
country: Portugal
facility: Site PT35133
city: Setubal
country: Portugal
facility: Site PT35122
city: Vila Nova de Gaia
country: Portugal
facility: Site PT35132
city: Bucharest
country: Romania
facility: Site RO40003
city: Bucharest
country: Romania
facility: Site RO40021
city: Bucuresti
country: Romania
facility: Site RO40012
city: Oradea
country: Romania
facility: Site RO40004
city: Chelyabinsk
country: Russian Federation
facility: Site RU70024
city: Irkutsk
country: Russian Federation
facility: Site RU70054
city: Moscow
country: Russian Federation
facility: Site RU70047
city: Moscow
country: Russian Federation
facility: Site RU70006
city: Nizhny Novgorod
country: Russian Federation
facility: Site RU70003
city: Omsk
country: Russian Federation
facility: Site RU70004
city: Rostov-on-Don
country: Russian Federation
facility: Site RU70014
city: Saint Petersburg
country: Russian Federation
facility: Site RU70011
city: Saint Petersburg
country: Russian Federation
facility: Site RU70002
city: Saratov
country: Russian Federation
facility: Site RU70060
city: Yaroslavl
country: Russian Federation
facility: Site RU70057
city: Yaroslavl
country: Russian Federation
facility: Site RU70001
city: Belgrade
country: Serbia
facility: Site RS38102
city: Belgrade
country: Serbia
facility: Site RS38105
city: Belgrade
country: Serbia
facility: Site RS38103
city: Belgrade
country: Serbia
facility: Site RS38104
city: Krusevac
country: Serbia
facility: Site RS38117
city: Nis
country: Serbia
facility: Site RS38101
city: Kosice
country: Slovakia
facility: Site SK42109
city: Košice
country: Slovakia
facility: Site SK42102
city: Puchov
country: Slovakia
facility: Site SK42113
city: Senica
country: Slovakia
facility: Site SK42116
city: Jesenice
country: Slovenia
facility: Site SI38615
city: Maribor
country: Slovenia
facility: Site SI38603
city: Slovenj Gradec
country: Slovenia
facility: Site SI38619
city: Šempeter pri Gorici
country: Slovenia
facility: Site SI38609
city: Ferrol
country: Spain
facility: Site ES34049
state: A Coruna
city: Barcelona
country: Spain
facility: Site ES34026
city: Cordoba
country: Spain
facility: Site ES34039
city: Girona
country: Spain
facility: Site ES34054
city: Jaen
country: Spain
facility: Site ES34017
city: Madrid
country: Spain
facility: Site ES34037
city: Madrid
country: Spain
facility: Site ES34010
city: Majadahonda
country: Spain
facility: Site ES34030
city: Santiago de Compostela
country: Spain
facility: Site ES34041
city: Lviv
country: Ukraine
facility: Site UA38009
state: Lvivska
city: Cherkasy
country: Ukraine
facility: Site UA38021
city: Dnipropetrovsk
country: Ukraine
facility: Site UA38006
city: Ivano-Frankivsk
country: Ukraine
facility: Site UA38016
city: Kharkiv
country: Ukraine
facility: Site UA38011
city: Kiev
country: Ukraine
facility: Site UA38017
city: Mykolaiv
country: Ukraine
facility: Site UA38007
city: Odessa
country: Ukraine
facility: Site UA38008
city: Ternopil
country: Ukraine
facility: Site UA38001
city: Uzhgorod
country: Ukraine
facility: Site UA38018
city: Dorchester
country: United Kingdom
facility: Site GB44098
state: Dorset
city: Birmingham
country: United Kingdom
facility: Site GB44064
city: Dartford
country: United Kingdom
facility: Site GB44099
city: Kings Lynn
country: United Kingdom
facility: Site GB44102
city: Leicester
country: United Kingdom
facility: Site GB44081
city: London
country: United Kingdom
facility: Site GB44086
city: London
country: United Kingdom
facility: Site GB44006
city: London
country: United Kingdom
facility: Site GB44082
city: Nottingham
country: United Kingdom
facility: Site GB44097
city: Orpington
country: United Kingdom
facility: Site GB44100
city: Preston
country: United Kingdom
facility: Site GB44101
city: Stoke-on-Trent
country: United Kingdom
facility: Site GB44080
city: Swansea
country: United Kingdom
facility: Site GB44001
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Monitor
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.