Clinical trial NCT00833768: 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
Official title: 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 (CKD) Patients Not on Dialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Hyperphosphatemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels
timeFrame: 24 weeks
Secondary outcomes:
measure: To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum total cholesterol and low density lipoprotein (LDL) cholesterol
timeFrame: 24 weeks
measure: To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse
city: Innsbruck
country: Austria
facility: Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie
city: Vienna
country: Austria
facility: Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse
city: Amiens
country: France
facility: CHU Amiens Sud Service de Néphrologie
city: Bordeaux Cedex
country: France
facility: Hôpital Pellegrin Service de Néphrologie
city: Cedex
country: France
facility: Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes
city: Cedex
country: France
facility: Service de Néphrologie Hémodialyse Clinique de l'Orangerie
city: Montpellier
country: France
facility: Hôpital La Peyronie Nephrologie
city: Paris
country: France
facility: Hôpital Tenon Néphrologie Hémodialyse
city: Vandoeuvre
country: France
facility: CHU de Brabois, Service de Néphrologie
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München, Nephrologie
city: Athens
country: Greece
facility: Ippokrateio Hospital of Athens
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Nikaia Peiraias
country: Greece
facility: General Hospital of Nikaia
city: Győr
country: Hungary
facility: Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension
city: Kaposvár
country: Hungary
facility: Kaposi Mór County Hospital Department of Nephrology
city: Szekszárd
country: Hungary
facility: Szekszárd EuroCare Dialysis Centre Number 7
city: Veszprém
country: Hungary
facility: Kórház u. 1
city: Lecco
country: Italy
facility: Azienda Ospedaliera di Lecco
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi
city: Roma
country: Italy
facility: Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini
city: Carnaxide
country: Portugal
facility: Hospital Santa Cruz
city: Coimbra
country: Portugal
facility: Centro Hospitalar de Coimbra - Serviço de Nefrologia
city: Coimbra
country: Portugal
facility: Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.
city: Porto
country: Portugal
facility: Hospital de São João EPE - Serviço de Nefrologia
city: Barcelona
country: Spain
facility: Servicio de nefrología Fundacion Puigvert
city: Ferrol
country: Spain
facility: Servicio de nefrología H. Arquitecto Marcide
city: Galdakao
country: Spain
facility: Servicio de nefrología Hospital de Galdakao
city: Madrid
country: Spain
facility: Servicio de nefrología Fundación Hospital Alcorcón
city: Valencia
country: Spain
facility: Servicio de Nefrología, Hospital Universitario Dr Peset,
city: Göteborg
country: Sweden
facility: Department of Nephrology Sahlgrenska University Hospital
city: Karlstad
country: Sweden
facility: NjurmedicinKliniken Centralsjukhuset
city: Stockholm
country: Sweden
facility: Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: