A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia

NCT02780726 | Completed Phase 3

• 1 other identifier: 1517-CL-0302
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 15

Brief Summary

The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal dialysis chronic kidney disease patients with anemia.

Conditions

Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia

Keywords

Peritoneal dialysis; Roxadustat; Renal anemia; ASP1517

Outcome Measures

Primary Outcomes (1)

• Hemoglobin (Hb) Response Rate from Week 18 to Week 24

  Hb response defined as average Hb within the target range in this outcome

  Up to Week 24

Secondary Outcomes (27)

• Hb Response rate

  Up to Week 24

• Average Hb levels from week 18 to week 24

  Up to week 24

• Change from baseline in the average Hb levels of week 18 to week 24

  Baseline and up to Week 24

• Rate of rise in Hb levels (g/dL/week)

  Up to Week 4

• Proportion of time points with target Hb levels

  Up to Week 24

Study Arms (3)

ASP1517 Low Dose Group (ESA Untreated)

EXPERIMENTAL

This group includes subjects who have not received Erythropoieses Stimulating Agents (ESAs). Study drug will be dosed three times weekly and dose adjustments will be made during the study.

Drug: roxadustat

ASP1517 High Dose Group (ESA Untreated)

EXPERIMENTAL

This group includes subjects who have not received ESAs. Study drug will be dosed three times weekly and dose adjustments will be made during the study.

Drug: roxadustat

ASP1517 ESAs Treated Group

EXPERIMENTAL

This group includes subjects who have received ESAs. The treatment was converted from ESAs to study drug. Study drug will be dosed three times weekly and dose adjustments will be made during the study.

Drug: roxadustat

Interventions

roxadustat DRUG

Oral

Also known as: ASP1517

ASP1517 ESAs Treated Group; ASP1517 High Dose Group (ESA Untreated); ASP1517 Low Dose Group (ESA Untreated)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subject must either:
• Be of non-childbearing potential:
• post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
• documented surgically sterile Or, if of childbearing potential,
• Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
• And have a negative pregnancy test at Screening
• And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration.
• Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
• Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
• Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration
• Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration
• Subjects who have not received Erythropoieses Stimulating Agents (ESAs):
• Subjects who have been receiving peritoneal dialysis for more than 4 weeks before the screening assessment
• Subjects who have never received ESAs after starting peritoneal dialysis, or subjects who have not received ESAs within 6 weeks before the screening assessment.
• Mean of the subject's two most recent Hb values before randomization during the Screening Period must be \<10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values

You may not qualify if:

• Subjects who had trouble with continuing peritoneal dialysis due to peritonitis, development of catheter trouble (e.g. tunnel infection) within 4 weeks before the screening assessment
• Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment
• Concurrent autoimmune disease with inflammation that could impact erythropoiesis
• History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastro-paresis
• Uncontrolled hypertension
• Concurrent congestive heart failure (NYHA Class III or higher)
• History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment
• Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
• Concurrent other form of anemia than renal anemia
• Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment
• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin, or Alkaline Phosphatase (ALP) that is greater than the criteria below, or previous or concurrent another serious liver disease at screening assessment
• Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
• Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) within 4 weeks before the screening assessment
• Having undergone a kidney transplantation
• Having a previous history of treatment with ASP1517

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Kyntra Bio: collaborator

Study Sites (15)

Site JP00002

Aichi, Japan

Location

Site JP00004

Aichi, Japan

Location

Site JP00010

Aichi, Japan

Location

Site JP00013

Aichi, Japan

Location

Site JP00001

Fukuoka, Japan

Location

Site JP00005

Fukuoka, Japan

Location

Site JP00012

Hokkaido, Japan

Location

Site JP00014

Hokkaido, Japan

Location

Site JP00006

Ishikawa, Japan

Location

Site JP00008

Kanagawa, Japan

Location

Site JP00003

Nagano, Japan

Location

SIte JP00015

Okayama, Japan

Location

Site JP00009

Osaka, Japan

Location

Site JP00007

Tokushima, Japan

Location

Site JP00011

Toyama, Japan

Location

Related Publications (2)

• Hamano T, Yamaguchi Y, Goto K, Mizokawa S, Ito Y, Dellanna F, Barratt J, Akizawa T. Risk Factors for Thromboembolic Events in Patients With Dialysis-Dependent CKD: Pooled Analysis of Phase 3 Roxadustat Trials in Japan. Adv Ther. 2024 Apr;41(4):1526-1552. doi: 10.1007/s12325-023-02727-3. Epub 2024 Feb 16.

  PMID: 38363463 DERIVED

• 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.

  PMID: 36005278 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Interventions

roxadustat

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 23, 2016
• Study Start: June 22, 2016
• Primary Completion: August 2, 2017
• Study Completion: August 2, 2017
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

JP (15)