ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

Astellas

Status and phase: Completed; Phase 2

Conditions: Anemia in Chronic Kidney Disease Patients Not on Dialysis

Treatments: Drug: Placebo; Drug: ASP1517

Study type: Interventional

Funder types: Industry

Identifiers

NCT01964196

1517-CL-0303

Details and patient eligibility

About

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.

Full description

To evaluate the safety and the dose-response of ASP1517 on Hemoglobin (Hb) correction in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently. Patients will receive ASP1517 three times a week (TIW) for first 6weeks. Patients may have the second-randomization to TIW dosing or once-a-week (QW) dosing at Week 6, 8, 10, 12, 14 or 16 if patients meet the criteria.

Enrollment: 107 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 4 patient groups, including a placebo group

ASP1517 low dose group

Experimental group

Description:

Oral

Treatment:

Drug: ASP1517

ASP1517 middle dose group

Experimental group

Description:

Oral

Treatment:

Drug: ASP1517

ASP1517 high dose group

Experimental group

Description:

Oral

Treatment:

Drug: ASP1517

Placebo group

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo