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

NCT ID: NCT01857024

Last Updated: 2015-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperphosphataemia Chronic Kidney Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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sevelamer carbonate (Renvela®)

800 mg tablets or 2.4 g powder for oral suspension should be administered as instructed in the Renvela® SmPC.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Graz, , Austria

Site Status

Linz, , Austria

Site Status

Aalborg, , Denmark

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Cabestany, , France

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Dijon, , France

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Lille, , France

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Saint-Laurent-du-Var, , France

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Toulouse, , France

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Berlin, , Germany

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Dortmund, , Germany

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Hanover, , Germany

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Mettmann, , Germany

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Wiesbaden, , Germany

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Acireale, , Italy

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Milan, , Italy

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Naples, , Italy

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Palermo, , Italy

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Pavia, , Italy

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Pesaro, , Italy

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Rome, , Italy

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Amsterdam, , Netherlands

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Breda, , Netherlands

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Dordrecht, , Netherlands

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Leiden, , Netherlands

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Madrid, , Spain

Site Status

Valencia, , Spain

Site Status

Countries

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Austria Denmark France Germany Italy Netherlands Spain

Other Identifiers

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SVCARB06009

Identifier Type: -

Identifier Source: org_study_id

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