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

Phase 3

Completed

• Conditions: Chronic Kidney Disease; Renal Dialysis; Renal Insufficiency
• Interventions: Drug: ASP1585; Drug: Sevelamer hydrochloride

• Registration Number: NCT01057407
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-27
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Chronic kidney disease patients on hemodialysis
• Hyperphosphatemia
• Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days
• Written informed consent

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Exclusion Criteria

• Patients with gastrointestinal surgery or enterectomy
• Patients with severe cardiac diseases
• Patients with severe constipation or diarrhea
• Patients with a history or complication of malignant tumors
• Patients with uncontrolled hypertension
• Patients treated with parathyroid intervention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP group	ASP1585	-
Sevelamer group	Sevelamer hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Serum phosphorus level at the end of treatment	After 12-week or at the treatment discontinuation

Secondary Outcome Measures

Name	Time	Method
Changes in serum Ca x P	During treatment
Changes in intact PTH levels	During Treatment
Change in serum phosphorus level	After 12-week or at the end of treatment
Time-course changes in serum phosphorus levels	During Treatment