Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

Phase 3

Completed

• Conditions: Hyperphosphatemia; Chronic Kidney Disease
• Interventions: Drug: SBR759A

• Registration Number: NCT01069692
• Lead Sponsor: Novartis

Brief Summary

This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2010-10
• Status Verified: 2011-07
• 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: 115

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 4	SBR759A	SBR759A
arm 5	SBR759A	-
Arm 1	SBR759A	Placebo
Arm 3	SBR759A	-
Arm 2	SBR759A	-

Primary Outcome Measures

Name	Time	Method
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment	6 weeks

Secondary Outcome Measures

Name	Time	Method
Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment	6 weeks
Evaluate dose-dependent efficacy of SBR759	6 weeks
Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo	6 weeks

Trial Locations

Locations (2)

Novartis Investigator Site; 🇮🇹 Lucca, Italy

Novartis Investigative Site; 🇮🇹 Siena, Italy