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

Chronic Kidney Disease Clinical Trial

— ASPIRE

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number	NCT00833768
Other study ID #	SVCARB00606
Secondary ID	Eudra CT: 2007-0
Status	Terminated
Phase	Phase 3
First received	January 29, 2009
Last updated	March 19, 2015
Start date	January 2009
Est. completion date	September 2009

Study information
Verified date	March 2015
Source	Sanofi
Contact	n/a
Is FDA regulated	No
Health authority	Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyAustria: Federal Office for Safety in Health CareSpain: Spanish Agency of MedicinesPortugal: National Pharmacy and Medicines InstituteGreece: National Organization of MedicinesItaly: Azienda Ospedaliera di Lecco
Study type	Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status	Terminated
Enrollment	5
Est. completion date	September 2009
Est. primary completion date	September 2009
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sevelamer carbonate
800mg tablets to be taken orally with meals three times per day
• Placebo for sevelamer carbonate
Placebo tablets to be taken orally with meals three times per day

Locations
Country	Name	City
Austria	Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse	Graz
Austria	Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck	Innsbruck
Austria	Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie	Linz
Austria	Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse	Vienna
France	CHU Amiens Sud Service de Néphrologie	Amiens
France	Hôpital Pellegrin Service de Néphrologie	Bordeaux Cedex
France	Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes	Cedex
France	Service de Néphrologie Hémodialyse Clinique de l'Orangerie	Cedex
France	Hôpital La Peyronie Nephrologie	Montpellier
France	Hôpital Tenon Néphrologie Hémodialyse	Paris
France	CHU de Brabois, Service de Néphrologie	Vandoeuvre
Germany	Klinikum Darmstadt	Darmstadt
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Klinikum rechts der Isar der TU München, Nephrologie	München
Greece	Ippokrateio Hospital of Athens	Athens
Greece	University Hospital of Ioannina	Ioannina
Greece	General Hospital of Nikaia	Nikaia Peiraias
Hungary	Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension	Gyor
Hungary	Kaposi Mór County Hospital Department of Nephrology	Kaposvár
Hungary	Szekszárd EuroCare Dialysis Centre Number 7	Szekszárd
Hungary	Kórház u. 1	Veszprém
Italy	Azienda Ospedaliera di Lecco	Lecco
Italy	Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi	Pavia
Italy	Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini	Roma
Portugal	Hospital Santa Cruz	Carnaxide
Portugal	Centro Hospitalar de Coimbra - Serviço de Nefrologia	Coimbra
Portugal	Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.	Coimbra
Portugal	Hospital de São João EPE - Serviço de Nefrologia	Porto
Spain	Servicio de nefrología Fundacion Puigvert	Barcelona
Spain	Servicio de nefrología H. Arquitecto Marcide	Ferrol
Spain	Servicio de nefrología Hospital de Galdakao	Galdakao
Spain	Servicio de nefrología Fundación Hospital Alcorcón	Madrid
Spain	Servicio de Nefrología, Hospital Universitario Dr Peset,	Valencia
Sweden	Department of Nephrology Sahlgrenska University Hospital	Göteborg
Sweden	NjurmedicinKliniken Centralsjukhuset	Karlstad
Sweden	Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna	Stockholm

Sponsors *(1)*
Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Austria, France, Germany, Greece, Hungary, Italy, Portugal, Spain, Sweden,

Outcome
Type	Measure	Time frame	Safety issue
Primary	To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels	24 weeks	Yes
Secondary	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	24 weeks	Yes
Secondary	To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)	24 weeks	Yes

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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

Clinical Trial Details — Status: Terminated

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Countries where clinical trial is conducted

Outcome