Status:
COMPLETED
Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Hyperphosphataemia
Chronic Kidney Disease
Eligibility:
All Genders
18-65 years
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 ...
Eligibility Criteria
Inclusion
- 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
- N/A
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01857024
Start Date
September 1 2010
End Date
October 1 2012
Last Update
March 23 2015
Active Locations (26)
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1
Graz, Austria
2
Linz, Austria
3
Aalborg, Denmark
4
Cabestany, France