NCT01857024CompletedNot Applicable
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
Genzyme, a Sanofi Company0 sites210 target enrollmentStarted: September 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 210
- Primary Endpoint
- Frequency of non-serious and Serious Adverse Drug Reaction (ADRs)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Frequency of non-serious and Serious Adverse Drug Reaction (ADRs)
Time Frame: 12 Months
Assess safety profile of Renvela tablets and powder
Secondary Outcomes
No secondary outcomes reported
Investigators
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