Anemia in Chronic Kidney Disease Patients Not on Dialysis Clinical Trial
Official title:
ASP1517 Phase 2 Clinical Trial -A Multi-center, Randomized, Parallel Groups, Placebo-controlled, Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-
| Verified date | April 2021 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.
| Status | Completed |
| Enrollment | 107 |
| Est. completion date | December 1, 2015 |
| Est. primary completion date | July 6, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 74 Years |
| Eligibility | Inclusion Criteria: - Chronic kidney disease with an estimated glomerular filtration rate (as calculated by the Japanese GFR estimation equation) of =<89 mL/min/1.73 m2, and not required dialysis for 3 months since study completion - The mean of two Hb values at screening test and Hb test (at least one week apart form the screening test) is <10.0 g/dL, with a difference of =1.0 g/dL between the two values - Both TSAT>=5% and ferritin >=30 ng/mL at screening test - Serum folate =4.0 ng/mL and Vitamin B12 =180 pg/mL at screening test 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 evidence of active gastroparesis. - Uncontrollable hypertension (more than one third blood pressure values of diastolic BP >100 mmHg within 16 weeks prior to screening test including) - Congestive heart failure (NYHA classification III or higher) - Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before screening test - Positive for any of the following: anti-hepatitis C virus antibody (anti-HCV Ab); hepatitis B surface antigen (HBsAg); or human immunodeficiency virus (HIV) - Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc) - Using ESA, anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before screening test |
| 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 Hb (g/dL/week) at Week 6 | Baseline and at 6 weeks after dosing | ||
| Secondary | Percentage of cumulative number of responder patients | responder is defined as a Hb =10.0 g/dL and an increase in Hb by =1.0 g/dL | for 28 weeks after dosing | |
| Secondary | Percentage of visits at which patients maintain Hb between 10.0-12.0 g/dL after achieving Hb =10.0 g/dL for each patients | for 28 weeks after dosing | ||
| Secondary | Percentage of patients who maintain Hb between 10.0-12.0 g/dL at each visit | Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28 | ||
| Secondary | Change from baseline in Hb | Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28 | ||
| Secondary | Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests | for 28 weeks after dosing |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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