Clinical trial NCT01964196: ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-
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-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia in Chronic Kidney Disease Patients Not on Dialysis
Keywords: Chronic Renal Failure
Renal anemia
ASP1517
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of rise in Hb (g/dL/week) at Week 6
timeFrame: Baseline and at 6 weeks after dosing
Secondary outcomes:
measure: Percentage of cumulative number of responder patients
timeFrame: for 28 weeks after dosing
measure: 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
timeFrame: for 28 weeks after dosing
measure: Percentage of patients who maintain Hb between 10.0-12.0 g/dL at each visit
timeFrame: Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28
measure: Change from baseline in Hb
timeFrame: Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28
measure: Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests
timeFrame: for 28 weeks after dosing
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
citation: Akizawa T, Iwasaki M, Otsuka T, Reusch M, Misumi T. Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. Adv Ther. 2019 Jun;36(6):1438-1454. doi: 10.1007/s12325-019-00943-4. Epub 2019 Apr 5.