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 (ASPIRE)

March 19, 2015 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo for sevelamer carbonate
Placebo tablets to be taken orally with meals three times per day
Active Comparator: Sevelamer carbonate
Drug: Sevelamer carbonate
800mg tablets to be taken orally with meals three times per day
Other Names:
  • Renvela(TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 24 weeks
24 weeks
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVCARB00606
  • Eudra CT: 2007-003885-16 (Registry Identifier: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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