Status:

TERMINATED

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

Lead Sponsor:

Genzyme, a Sanofi Company

Conditions:

Chronic Kidney Disease

Hyperphosphatemia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to de...

Eligibility Criteria

Inclusion

  • Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.

Exclusion

  • Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT00833768

Start Date

January 1 2009

End Date

September 1 2009

Last Update

March 24 2015

Active Locations (36)

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Page 1 of 9 (36 locations)

1

Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse

Graz, Austria

2

Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck

Innsbruck, Austria

3

Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie

Linz, Austria

4

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse

Vienna, Austria