Anemia in CKD patients not on dialysis MedDRA version: 20.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851
Conditions
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: - Age = 18 years - Diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis; with an eGFR =65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: Subject will be excluded from participation if any of the following apply: - Any ESA treatment within 12 weeks prior to randomization. - More than one dose of IV iron within 12 weeks prior to randomization. - RBC transfusion within 8 weeks prior to randomization. - chronic inflammatory disease that could impact erythropoiesis even if it is currently in remission. - myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization. - two or more blood pressure values of systolic BP (SBP) = 160 mmHg or diastolic BP (DPB) = 95 mmHg confirmed by repeat measurement within 2 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of FG-4592 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) subjects.; Secondary Objective: - To evaluate the safety of FG-4592. - To evaluate health-related quality of life benefit. - To evaluate the need for rescue therapy. (RBC transfusion, ESA, or IV Iron) ;Timepoint(s) of evaluation of this end point: Up to and including week 24; Primary end point(s): 1. The EU (EMA) primary efficacy endpoint is Hb response. Hb response is defined as: •Hb 11.0 g/dL and a Hb increase from BL by 1.0 g/dL in any subject with BL Hb > 8.0 g/dL, OR •an increase from BL by 2.0 g/dL in any subject with BL Hb = 8.0 g/dL at two consecutive visits separated by at least 5 days during the first 24 weeks of treatment without rescue therapy (i.e., RBC transfusion, ESA, or IV iron) prior to Hb response. 2. The US (FDA) primary efficacy endpoint is the change in Hb from baseline to the average level during the evaluation period (defined as Week 28 until Week 52) regardless of rescue therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Hb maintenance: Hb change from BL to the average Hb of weeks 28-36, 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 in weeks 12-28. •Blood pressure effect •Change from BL in Mean Arterial Pressure (MAP) to the average MAP in weeks 20-28. •Occurrence, and time to occurrence of hypertension (defined as either SBP >170 mmHg AND an increase from BL = 20 mmHg or as DBP > 110 mmHg, AND an increase from BL = 15 mmHg on 2 consecutive visits). •Use and time to use of rescue therapy (composite of RBC transfusions, ESA use, and IV iron) in the first 24 weeks of treatment. •Change from BL in SF-36 Physical Functioning (PF) subscore to the average SF-36 PF subscore in weeks 12-28. •Change from BL in SF-36 Vitality (VT) subscore to the average SF-36 VT subscore in weeks 12-28. ;Timepoint(s) of evaluation of this end point: Week 12 to week 28 | — |
Countries
Belarus, Belgium, Bulgaria, Colombia, Dominican Republic, Estonia, Georgia, Greece, Guatemala, Hungary, Italy, Panama, Peru, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Turkey, Ukraine, United Kingdom
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V. -Global Clinical Dev.
Outcome results
None listed