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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra CT: 2007-003885-16 | Registry Identifier | EudraCT |
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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevelamer carbonate | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer carbonate | Drug | 800mg tablets to be taken orally with meals three times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels | 24 weeks |
| Measure | Description | 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse | Graz | Austria | ||||
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| Placebo for sevelamer carbonate | Drug | Placebo tablets to be taken orally with meals three times per day |
|
| 24 weeks |
| 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 | 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 | Vandœuvre-lès-Nancy | France |
| Klinikum Darmstadt | Darmstadt | Germany |
| Medizinische Hochschule Hannover | Hanover | 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 | Gothenburg | Sweden |
| NjurmedicinKliniken Centralsjukhuset | Karlstad | Sweden |
| Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna | Stockholm | Sweden |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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