Status:
COMPLETED
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
Lead Sponsor:
Astellas Pharma Europe B.V.
Collaborating Sponsors:
FibroGen
Conditions:
Anemia
End Stage Renal Disease (ESRD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (w...
Detailed Description
This study consisted of three study periods as follows: * Screening Period: up to 6 weeks * Treatment Period: a minimum of 52 weeks up to a maximum of 104 weeks * Follow-up Period: 4 weeks
Eligibility Criteria
Inclusion
- Main Inclusion:
- Participant is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to randomization.
- Participant is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks prior to randomization with stable weekly doses (during 4 weeks prior to randomization).
- Mean of the participant's three most recent Hb values, as measured by central laboratory, during the Screening Period.
- Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN
Exclusion
- Main Exclusion:
- Participant has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization.
- Participant 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).
- Participant has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
- Participant has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization.
- Participant has a history of malignancy, except for the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
- Participant has had any prior organ transplant (that has not been explanted), or participant is scheduled for organ transplantation.
Key Trial Info
Start Date :
November 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2018
Estimated Enrollment :
838 Patients enrolled
Trial Details
Trial ID
NCT02278341
Start Date
November 21 2014
End Date
July 6 2018
Last Update
November 27 2024
Active Locations (143)
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1
Site BE32004
Brussels, Flemish Brabant, Belgium, 1200
2
Site BE32001
Aalst, Belgium, 9300
3
Site BE32019
Antwerp, Belgium, 2020
4
Site BE32002
Antwerp, Belgium, 2060