Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Sevelamer HCl; Drug: SBR759

• Registration Number: NCT00704678
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-24
• Study First Posted: 2008-06-25
• Study Start: 2008-08
• Primary Completion: 2010-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Sevelamer HCl	1.5 g tid
1	SBR759	1g bid
2	Sevelamer HCl	0.8 g tid
4	Sevelamer HCl	1.6 g tid

Primary Outcome Measures

Name	Time	Method
Responder rates achieving target serum phosphate levels.	Week 12

Secondary Outcome Measures

Name	Time	Method
Responder rates in target patients with serum calcium-phosphate levels.	Week 12

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Taipei, Taiwan