Anemia in End Stage Renal Disease (ESRD) subjects on stable dialysis. MedDRA version: 20.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000012844
Conditions
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject age is =18 years. Subject is on stable HD, HDF or PD treatment with the same mode of dialysis for =4 months prior to randomization. Subject is on IV or SC epoetin (i.e. epoetin alfa, beta, theta, zeta, delta or omega) or IV or SC darbepoetin alfa treatment for =8 weeks prior to randomization with stable weekly doses. Mean of the subject’s three most recent Hb values, as measured by central laboratory, during the Screening Period. Subject’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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization. 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 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. Subject has had uncontrolled hypertension, in the opinion of the investigator, within two weeks prior to randomization. Subject 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. Subject has had any prior organ transplant (that has not been explanted), or subject is scheduled for organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of roxadustat compared to epoetin alfa and darbepoetin alfa in the maintenance treatment of anemia in End Stage Renal Disease (ESRD) subjects on stable dialysis. ; Secondary Objective: Evaluate the safety of roxadustat compared to epoetin alfa and darbepoetin alfa in the maintenance treatment of anemia in ESRD subjects on stable dialysis. Evaluate the effects on health-related quality of life of roxadustat compared to epoetin alfa and darbepoetin alfa in the maintenance treatment of anemia in ESRD subjects on stable dialysis. ; Primary end point(s): There are two separate regionally based primary efficacy endpoints in this study, depending upon whether the data are being filed to support submission to the US Food and Drug Administration (FDA) or to Ex-US health authorities, such as the European Medicines Agency (EMA). ? The EU (EMA) primary efficacy endpoint is change in Hb from baseline (BL) to the average level during the evaluation period (defined as week 28 until week 36), without having received rescue therapy (i.e. RBC transfusion for all subjects or ESA for subjects treated with roxadustat) within 6 weeks prior to and during this 8-week evaluation period. ? The US (FDA) primary efficacy endpoint is change in Hb from BL to the average level during the evaluation period (defined as week 28 until week 52), regardless of rescue therapy. ;Timepoint(s) of evaluation of this end point: 36 weeks (for EU primary endpoint) or 52 weeks (for US primary enpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hb response defined as mean Hb during weeks 28 to 36 within the target range of 10.0 to 12.0 g/dL without having received rescue therapy within 6 weeks prior to and during this 8 week evaluation period. Change from BL in Short Form 36 (SF-36) Physical Functioning(PF) sub-score to the average PF sub-score of weeks 12 to 28. Change from BL in SF-36 Vitality (VT) sub-score to the average VT sub-score of weeks 12 to 28. ;Timepoint(s) of evaluation of this end point: 36 weeks | — |
Countries
Belgium, Bulgaria, Croatia, Czech Republic, France, Georgia, Germany, Hungary, Italy, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, United Kingdom
Contacts
Public ContactService Desk - Global Clinical Dev.
Astellas Pharma Europe B.V.
Outcome results
None listed