Renal Anemia Associated With Chronic Renal Failure (CRF) Clinical Trial
Official title:
A Japanese, Phase 2, Multicenter, Randomized, 4-arm Parallel, Double-blind (Arms 1-3), Open-label (Arm 4), Active-comparator (Darbepoetin Alfa) Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis-dependent Chronic Kidney Disease Patients With Anemia
| Verified date | December 2019 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in dialysis chronic kidney disease patients with anemia.
| Status | Completed |
| Enrollment | 130 |
| Est. completion date | September 15, 2014 |
| Est. primary completion date | September 15, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Patients who diagnosed as a end-stage kidney disease (ESKD) and are receiving stable chronic maintenance dialysis 3 times per week for = 12 weeks - Patients who are receiving ESA for at least 8 weeks and the dose of ESA is within the dose range of ESA label - Hb value at screening test is =10.0 g/dL - Receiving hemodialysis via arteriovenous fistula (AVF) or arteriovenous graft (AVG) or via permanent catheter - Most recent two Hb values before dialysis during washout period must be both <9.5 g/dL and one of two Hb values must be tested on first visit of the week Exclusion Criteria: - Proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment - Immunological disease with severe inflammation as assessed by the Investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, celiac disease, etc) - Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or active gastroparesis - Uncontrollable hypertension (SBP =160 mmHg and DBP =110 mmHg, before dialysis, at screening test) - Congestive heart failure (NYHA classification III or higher) - Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before 1st registration - Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab) - Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc) - Pure red cell aplasia - Using anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before 1st registration |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of rise in hemoglobin (g/dL/week) | Baseline and at Week-6 | ||
| Secondary | Cumulative number of responder patients | Responder is defined as a hemoglobin >10.0 g/dL and an increase in hemoglobin by >1.0 g/dL from baseline | up to Week-24 | |
| Secondary | Percent of visits at which patients maintain hemoglobin between 10.0-12.0 g/dL after achieving hemoglobin =10.0 g/dL for each patients | for 28 weeks after dosing | ||
| Secondary | Percent of patients who maintain hemoglobin between 10.0-12.0 g/dL at each visit | for 28 weeks after dosing |