Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia

Completed

• Conditions: Chronic Kidney Disease; Hyperphosphataemia

• Registration Number: NCT01857024
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L.
• Prescribed Renvela (800 mg tablets or 2.4 g powder for oral suspension) in accordance with the Renvela SmPC.
• Provide signed informed consent (patient or their legally authorised representative)

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of non-serious and Serious Adverse Drug Reaction (ADRs)	12 Months	Assess safety profile of Renvela tablets and powder