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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 (ASPIRE)

Primary Purpose

Chronic Kidney Disease, Hyperphosphatemia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sevelamer carbonate
Placebo for sevelamer carbonate
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sevelamer carbonate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels

Secondary Outcome Measures

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
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)

Full Information

First Posted
January 29, 2009
Last Updated
March 19, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00833768
Brief 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 Patients Not on Dialysis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame.
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevelamer carbonate
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate
Other Intervention Name(s)
Renvela(TM)
Intervention Description
800mg tablets to be taken orally with meals three times per day
Intervention Type
Drug
Intervention Name(s)
Placebo for sevelamer carbonate
Intervention Description
Placebo tablets to be taken orally with meals three times per day
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse
City
Graz
Country
Austria
Facility Name
Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie
City
Linz
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse
City
Vienna
Country
Austria
Facility Name
CHU Amiens Sud Service de Néphrologie
City
Amiens
Country
France
Facility Name
Hôpital Pellegrin Service de Néphrologie
City
Bordeaux Cedex
Country
France
Facility Name
Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes
City
Cedex
Country
France
Facility Name
Service de Néphrologie Hémodialyse Clinique de l'Orangerie
City
Cedex
Country
France
Facility Name
Hôpital La Peyronie Nephrologie
City
Montpellier
Country
France
Facility Name
Hôpital Tenon Néphrologie Hémodialyse
City
Paris
Country
France
Facility Name
CHU de Brabois, Service de Néphrologie
City
Vandoeuvre
Country
France
Facility Name
Klinikum Darmstadt
City
Darmstadt
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München, Nephrologie
City
München
Country
Germany
Facility Name
Ippokrateio Hospital of Athens
City
Athens
Country
Greece
Facility Name
University Hospital of Ioannina
City
Ioannina
Country
Greece
Facility Name
General Hospital of Nikaia
City
Nikaia Peiraias
Country
Greece
Facility Name
Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension
City
Győr
Country
Hungary
Facility Name
Kaposi Mór County Hospital Department of Nephrology
City
Kaposvár
Country
Hungary
Facility Name
Szekszárd EuroCare Dialysis Centre Number 7
City
Szekszárd
Country
Hungary
Facility Name
Kórház u. 1
City
Veszprém
Country
Hungary
Facility Name
Azienda Ospedaliera di Lecco
City
Lecco
Country
Italy
Facility Name
Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi
City
Pavia
Country
Italy
Facility Name
Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini
City
Roma
Country
Italy
Facility Name
Hospital Santa Cruz
City
Carnaxide
Country
Portugal
Facility Name
Centro Hospitalar de Coimbra - Serviço de Nefrologia
City
Coimbra
Country
Portugal
Facility Name
Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.
City
Coimbra
Country
Portugal
Facility Name
Hospital de São João EPE - Serviço de Nefrologia
City
Porto
Country
Portugal
Facility Name
Servicio de nefrología Fundacion Puigvert
City
Barcelona
Country
Spain
Facility Name
Servicio de nefrología H. Arquitecto Marcide
City
Ferrol
Country
Spain
Facility Name
Servicio de nefrología Hospital de Galdakao
City
Galdakao
Country
Spain
Facility Name
Servicio de nefrología Fundación Hospital Alcorcón
City
Madrid
Country
Spain
Facility Name
Servicio de Nefrología, Hospital Universitario Dr Peset,
City
Valencia
Country
Spain
Facility Name
Department of Nephrology Sahlgrenska University Hospital
City
Göteborg
Country
Sweden
Facility Name
NjurmedicinKliniken Centralsjukhuset
City
Karlstad
Country
Sweden
Facility Name
Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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