A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

NCT ID: NCT00505037

Last Updated: 2011-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-09-30

Brief Summary

To evaluate the superiority to placebo, dose-responsibility and safety.

Detailed Description

This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.

Conditions

Hyperphosphatemia; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ASP1585 dose #1

Group Type: EXPERIMENTAL

ASP1585

Intervention Type: DRUG

Oral

ASP1585 dose #2

Group Type: EXPERIMENTAL

ASP1585

Intervention Type: DRUG

Oral

ASP1585 dose #3

Group Type: EXPERIMENTAL

ASP1585

Intervention Type: DRUG

Oral

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral

Sevelamer hydrochloride

Group Type: ACTIVE_COMPARATOR

Sevelamer hydrochloride

Intervention Type: DRUG

Oral

Interventions

ASP1585

Oral

Intervention Type: DRUG

Placebo

Oral

Intervention Type: DRUG

Sevelamer hydrochloride

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
• Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
• Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents

Exclusion Criteria

• History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
• Continuous severe constipation/diarrhea.
• History of parathyroid intervention [parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.] within 1 year of the acquisition of informed consent
• Diet restriction such as fasting and/or excessive dieting
• Uncontrolled hypertension

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Astellas Pharma Inc.

Principal Investigators

Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Chugoku, , Japan

Chūbu, , Japan

Kansai, , Japan

Kanto, , Japan

Kyushu, , Japan

Shikoku, , Japan

Countries

Japan

References

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

Akizawa T, Origasa H, Kameoka C, Kaneko Y, Kanoh H. Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group study. Ther Apher Dial. 2014 Jun;18 Suppl 2:24-32. doi: 10.1111/1744-9987.12202.

Reference Type: DERIVED

PMID: 24975892 (View on PubMed)

Other Identifiers

1585-CL-0002

Identifier Type: -

Identifier Source: org_study_id