NCT01857024

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

Renvela® Post-Marketing Observational Study to Monitor the Clinical Use in Adult Hyperphosphataemic Chronic Kidney Disease Patients Not On Dialysis With Serum Phosphorus ≥1.78 mmol/L

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperphosphataemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	sevelamer carbonate (Renvela®)	800 mg tablets or 2.4 g powder for oral suspension should be administered as instructed in the Renvela® SmPC.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-05-20
• Last updated: 2015-03-23

Locations

26 sites across 7 countries: Austria, Denmark, France, Germany, Italy, Netherlands, Spain