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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857024
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( 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.

Condition or disease Intervention/treatment
Hyperphosphataemia Chronic Kidney Disease Drug: sevelamer carbonate (Renvela®)

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : September 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Frequency of non-serious and Serious Adverse Drug Reaction (ADRs) [ Time Frame: 12 Months ]
    Assess safety profile of Renvela tablets and powder



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857024


Locations
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Austria
Graz, Austria
Linz, Austria
Denmark
Aalborg, Denmark
France
Cabestany, France
Dijon, France
Lille, France
St. Laurent du Var, France
Toulouse, France
Germany
Berlin, Germany
Dortmund, Germany
Hannover, Germany
Mettman, Germany
Wiesbaden, Germany
Italy
Acireale, Italy
Milano, Italy
Naples, Italy
Palermo, Italy
Pavia, Italy
Pesaro, Italy
Rome, Italy
Netherlands
Amsterdam, Netherlands
Breda, Netherlands
Dordrecht, Netherlands
Leiden, Netherlands
Spain
Madrid, Spain
Valencia, Spain
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01857024    
Other Study ID Numbers: SVCARB06009
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action