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Clinical Trial Details

Trial ID: L0498
Source ID: NCT00833768
Associated Drug: Sevelamer Carbonate
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
Status: TERMINATED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Hyperphosphatemia
Interventions: DRUG: Sevelamer carbonate|DRUG: Placebo for sevelamer carbonate
Outcome Measures: Primary: To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels, 24 weeks | 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|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
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 5
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-01
Completion Date: 2009-09
Results First Posted:
Last Update Posted: 2015-03-24
Locations: 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, Austria|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, France|Klinikum Darmstadt, Darmstadt, Germany|Medizinische Hochschule Hannover, Hannover, Germany|Klinikum rechts der Isar der TU München, Nephrologie, München, Germany|Ippokrateio Hospital of Athens, Athens, Greece|University Hospital of Ioannina, Ioannina, Greece|General Hospital of Nikaia, Nikaia Peiraias, Greece|Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension, Győr, Hungary|Kaposi Mór County Hospital Department of Nephrology, Kaposvár, Hungary|Szekszárd EuroCare Dialysis Centre Number 7, Szekszárd, Hungary|Kórház u. 1, Veszprém, Hungary|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, Italy|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, Portugal|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, Spain|Department of Nephrology Sahlgrenska University Hospital, Göteborg, Sweden|NjurmedicinKliniken Centralsjukhuset, Karlstad, Sweden|Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna, Stockholm, Sweden
URL: https://clinicaltrials.gov/show/NCT00833768

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