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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

NCT ID: NCT00833768

Last Updated: 2015-03-24

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sevelamer carbonate

Group Type ACTIVE_COMPARATOR

Sevelamer carbonate

Intervention Type DRUG

800mg tablets to be taken orally with meals three times per day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo for sevelamer carbonate

Intervention Type DRUG

Placebo tablets to be taken orally with meals three times per day

Interventions

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Sevelamer carbonate

800mg tablets to be taken orally with meals three times per day

Intervention Type DRUG

Placebo for sevelamer carbonate

Placebo tablets to be taken orally with meals three times per day

Intervention Type DRUG

Other Intervention Names

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Renvela(TM)

Eligibility Criteria

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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.
Minimum Eligible Age

18 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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Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse

Graz, , Austria

Site Status

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

Innsbruck, , Austria

Site Status

Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie

Linz, , Austria

Site Status

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

Vienna, , Austria

Site Status

CHU Amiens Sud Service de Néphrologie

Amiens, , France

Site Status

Hôpital Pellegrin Service de Néphrologie

Bordeaux, , France

Site Status

Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes

Cedex, , France

Site Status

Service de Néphrologie Hémodialyse Clinique de l'Orangerie

Cedex, , France

Site Status

Hôpital La Peyronie Nephrologie

Montpellier, , France

Site Status

Hôpital Tenon Néphrologie Hémodialyse

Paris, , France

Site Status

CHU de Brabois, Service de Néphrologie

Vandœuvre-lès-Nancy, , France

Site Status

Klinikum Darmstadt

Darmstadt, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Klinikum rechts der Isar der TU München, Nephrologie

München, , Germany

Site Status

Ippokrateio Hospital of Athens

Athens, , Greece

Site Status

University Hospital of Ioannina

Ioannina, , Greece

Site Status

General Hospital of Nikaia

Nikaia Peiraias, , Greece

Site Status

Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension

Győr, , Hungary

Site Status

Kaposi Mór County Hospital Department of Nephrology

Kaposvár, , Hungary

Site Status

Szekszárd EuroCare Dialysis Centre Number 7

Szekszárd, , Hungary

Site Status

Kórház u. 1

Veszprém, , Hungary

Site Status

Azienda Ospedaliera di Lecco

Lecco, , Italy

Site Status

Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi

Pavia, , Italy

Site Status

Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini

Roma, , Italy

Site Status

Hospital Santa Cruz

Carnaxide, , Portugal

Site Status

Centro Hospitalar de Coimbra - Serviço de Nefrologia

Coimbra, , Portugal

Site Status

Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.

Coimbra, , Portugal

Site Status

Hospital de São João EPE - Serviço de Nefrologia

Porto, , Portugal

Site Status

Servicio de nefrología Fundacion Puigvert

Barcelona, , Spain

Site Status

Servicio de nefrología H. Arquitecto Marcide

Ferrol, , Spain

Site Status

Servicio de nefrología Hospital de Galdakao

Galdakao, , Spain

Site Status

Servicio de nefrología Fundación Hospital Alcorcón

Madrid, , Spain

Site Status

Servicio de Nefrología, Hospital Universitario Dr Peset,

Valencia, , Spain

Site Status

Department of Nephrology Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

NjurmedicinKliniken Centralsjukhuset

Karlstad, , Sweden

Site Status

Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna

Stockholm, , Sweden

Site Status

Countries

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Austria France Germany Greece Hungary Italy Portugal Spain Sweden

Other Identifiers

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Eudra CT: 2007-003885-16

Identifier Type: REGISTRY

Identifier Source: secondary_id

SVCARB00606

Identifier Type: -

Identifier Source: org_study_id

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