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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857024
• Other study ID #: SVCARB06009
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: March 19, 2015
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphataemia
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• sevelamer carbonate (Renvela®)
800 mg tablets or 2.4 g powder for oral suspension should be administered as instructed in the Renvela® SmPC.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of non-serious and Serious Adverse Drug Reaction (ADRs)	Assess safety profile of Renvela tablets and powder	12 Months	Yes