Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

Phase 2

Completed

• Conditions: Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
• Interventions: Drug: Sevelamer HCl; Drug: SBR759

• Registration Number: NCT00704483
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in 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: 2008-07
• Primary Completion: 2010-08
• Status Verified: 2016-11
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-28
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks	Time Frame: 12 weeks + 12 months

Secondary Outcome Measures

Name	Time	Method
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months	Time Frame: 12 weeks / 12 months

Trial Locations

Locations (3)

Novartis; 🇬🇧 Salford, United Kingdom

Novartis Investigative Site; 🇬🇧 Portsmouth, United Kingdom

Novarits; 🇺🇸 Fargo, North Dakota, United States