NCT00505037

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

A Phase 2, Randomized, Double-blind-placebo-controlled and Open-label-Sevelamer Hydrochloride-controlled, Dose-ranging Study for ASP1585 in Patients With Chronic Kidney Disease(CKD) and Hyperphosphatemia on Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	ASP1585	Oral
DRUG	Placebo	Oral
DRUG	Sevelamer hydrochloride	Oral

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-07-20
• Last updated: 2011-03-22

Locations

6 sites across 1 country: Japan