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

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-

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.

Study Overview

• Status: Completed
• Conditions: Anemia in Chronic Kidney Disease Patients Not on Dialysis
• Intervention / Treatment: Drug: Placebo; Drug: ASP1517

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
  • Hokkaido, Japan
  • Kansai, Japan
  • Kanto, Japan
  • Kyushu, Japan
  • Shikoku, Japan
  • Tohoku, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP1517 low dose group; Oral	Drug: ASP1517; Oral administration
Experimental: ASP1517 middle dose group; Oral	Drug: ASP1517; Oral administration
Experimental: ASP1517 high dose group; Oral	Drug: ASP1517; Oral administration
Placebo Comparator: Placebo group; Oral	Drug: Placebo; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of rise in Hb (g/dL/week) at Week 6	Baseline and at 6 weeks after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change from baseline in Hb		Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28
Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests		for 28 weeks after dosing

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Medical Director, Astellas Pharma Inc

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Link to results on the Astellas Clinical Study Results website.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2013
• Primary Completion (Actual): July 6, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimated): October 17, 2013

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Renal Failure; Renal anemia; ASP1517
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia
• Other Study ID Numbers: 1517-CL-0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No