Anemia in Chronic Kidney Disease patients not on Dialysis MedDRA version: 20.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851
Conditions
Interventions
Product Name: Roxadustat
Product Code: FG-4592/ASP1517 20mg
Pharmaceutical Form: Tablet
INN or Proposed INN: roxadustat
CAS Number: 808118-40-3
Current Sponsor code: FG-4592
Other descriptive name: AS
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is eligible for the study if all of the following apply: Subject age is = 18 years. Subject has a diagnosis of CKD, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not on dialysis; with an eGFR =65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: Subject will be excluded from participation if any of the following apply: Subject has received any 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 chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission. 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 an uncontrolled hypertension in the opinion of the investigator, or two or more blood pressure values of systolic blood pressure (SBP) =160 mmHg or diastolic blood pressure (DBP) =95mm Hg, within 2 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of roxadustat compared to Darbepoetin alfa in the treatment of anemia in non-dialysis dependent Chronic Kidney Disease (NDD-CKD) subjects.;Secondary Objective: Evaluate the safety of roxadustat compared to Darbepoetin alfa in the treatment of anemia in NDD-CKD subjects. Evaluate the health-related quality of life (HRQoL) benefit of roxadustat compared to Darbepoetin alfa in the treatment of anemia in NDD-CKD subjects.;Primary end point(s): The primary efficacy endpoint is Hb response defined as: - Hb =11.0 g/dL and a Hb increase from BL Hb by =1.0 g/dL in any subject with BL Hb>8.0 g/dL, OR - An increase from BL Hb by =2.0 g/dL in any subject with BL Hb =8.0 g/dL as measured at 2 consecutive visits separated by at least 5 days during the first 24 weeks of treatment without administration of rescue therapy prior to Hb response.;Timepoint(s) of evaluation of this end point: 36 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Hb change from BL Hb to the average Hb of weeks 28 to 36, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period - Change from BL in Low Density Lipoprotein (LDL) cholesterol to the average LDL cholesterol of weeks 12 to 28 - Mean monthly IV iron (mg) use per subject during weeks 1 to 36 (monthly defined as a period of 4 weeks) - Change from BL in SF-36 Physical Functioning (PF) sub-core to the average PF sub-score of weeks 12 to 28 - Change from BL in SF 36 Vitality (VT) sub-core to the average VT sub-score of weeks 20 to 28. - Blood pressure effect: o Change from BL in mean arterial pressure (MAP) to the average MAP value of weeks 20 to 28 o Occurrence & time to occurrence of hypertension (defined as either systolic blood pressure [SBP] >170 mmHg AND an increase from BL of =20 mmHg SBP or diastolic blood pressure [DBP] >110 mmHg AND an increase from BL of =15 mmHg DBP on 2 consecutive visits) during weeks 1 to 36 - Change from BL in SF-36 Physical Functioning (PF) sub-score to the average PF subscore 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
Austria, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Hungary, Ireland, Israel, Latvia, Macedonia, the former Yugoslav Republic of, Montenegro, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Ukraine, United Kingdom
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V.- Global Development Operations
Outcome results
None listed