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

Phase 2

Completed

• Conditions: Hyperphosphatemia; Chronic Kidney Disease
• Interventions: Drug: ASP1585; Drug: Placebo; Drug: Sevelamer hydrochloride

• Registration Number: NCT00505037
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study First Submitted: 2007-07-18
• Study First Submitted QC: 2007-07-18
• Study First Posted: 2007-07-20
• Study Start: 2007-10
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-21
• Last Update Posted: 2011-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP1585 dose #2	ASP1585	-
ASP1585 dose #3	ASP1585	-
Placebo	Placebo	-
Sevelamer hydrochloride	Sevelamer hydrochloride	-
ASP1585 dose #1	ASP1585	-

Primary Outcome Measures

Name	Time	Method
Change in serum phosphorus	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Ca×P	4 weeks
Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time	4 Weeks
Change in serum phosphorus level by time	Up to 4 weeks
Change in corrected serum Ca level	4 weeks
Change in intact PTH	4 weeks