Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-03 @ 5:43 AM
Study NCT ID:
NCT00833768
Status:
TERMINATED
Last Update Posted:
2015-03-24
First Post:
2009-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069603', 'term': 'Sevelamer'}], 'ancestors': [{'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2009-01-29', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '24 weeks'}, {'measure': 'To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP)', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease', 'Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.'}, 'identificationModule': {'nctId': 'NCT00833768', 'acronym': 'ASPIRE', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SVCARB00606'}, 'secondaryIdInfos': [{'id': 'Eudra CT: 2007-003885-16', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevelamer carbonate', 'interventionNames': ['Drug: Sevelamer carbonate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo for sevelamer carbonate']}], 'interventions': [{'name': 'Sevelamer carbonate', 'type': 'DRUG', 'otherNames': ['Renvela(TM)'], 'description': '800mg tablets to be taken orally with meals three times per day', 'armGroupLabels': ['Sevelamer carbonate']}, {'name': 'Placebo for sevelamer carbonate', 'type': 'DRUG', 'description': 'Placebo tablets to be taken orally with meals three times per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens Sud Service de Néphrologie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Pellegrin Service de Néphrologie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Cedex', 'country': 'France', 'facility': 'Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes'}, {'city': 'Cedex', 'country': 'France', 'facility': "Service de Néphrologie Hémodialyse Clinique de l'Orangerie"}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital La Peyronie Nephrologie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Tenon Néphrologie Hémodialyse', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU de Brabois, Service de Néphrologie', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Klinikum Darmstadt', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'München', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar der TU München, Nephrologie', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Ippokrateio Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Ioannina', 'country': 'Greece', 'facility': 'University Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'city': 'Nikaia Peiraias', 'country': 'Greece', 'facility': 'General Hospital of Nikaia'}, {'city': 'Győr', 'country': 'Hungary', 'facility': 'Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Kaposvár', 'country': 'Hungary', 'facility': 'Kaposi Mór County Hospital Department of Nephrology', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'city': 'Szekszárd', 'country': 'Hungary', 'facility': 'Szekszárd EuroCare Dialysis Centre Number 7', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'city': 'Veszprém', 'country': 'Hungary', 'facility': 'Kórház u. 1', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'city': 'Lecco', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Lecco', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Roma', 'country': 'Italy', 'facility': "Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Carnaxide', 'country': 'Portugal', 'facility': 'Hospital Santa Cruz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Coimbra - Serviço de Nefrologia', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital de São João EPE - Serviço de Nefrologia', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Servicio de nefrología Fundacion Puigvert', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Ferrol', 'country': 'Spain', 'facility': 'Servicio de nefrología H. Arquitecto Marcide', 'geoPoint': {'lat': 43.48451, 'lon': -8.23293}}, {'city': 'Galdakao', 'country': 'Spain', 'facility': 'Servicio de nefrología Hospital de Galdakao', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Servicio de nefrología Fundación Hospital Alcorcón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Servicio de Nefrología, Hospital Universitario Dr Peset,', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Department of Nephrology Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Karlstad', 'country': 'Sweden', 'facility': 'NjurmedicinKliniken Centralsjukhuset', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}