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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00681941 |
Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Disease Hyperphosphatemia |
Drug: Sevelamer carbonate (Renvela®) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis |
Enrollment: | 49 |
Study Start Date: | January 2006 |
Study Completion Date: | March 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Sevelamer Carbonate Tablets Dosed Three Times A Day
|
Drug: Sevelamer carbonate (Renvela®)
Sevelamer Carbonate Tablets Dosed Three Times A Day
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Queensland | |
Nephrology Department, Princess Alexandra Hospital | |
Wooloongabba, Queensland, Australia, 4102 | |
Australia, South Australia | |
Renal Unit, The Queen Elizabeth Hospital | |
Woodville, South Australia, Australia, 5011 | |
Australia, Tasmania | |
Renal Research Unit, Launceston General Hospital | |
Launceston, Tasmania, Australia, 7250 | |
Australia, Victoria | |
The Royal Melbourne Hospital, Department of Nephrology | |
Parkville, Victoria, Australia, 3050 | |
Melbourne Renal Research Group, Epworth Medical Centre | |
Richmond, Victoria, Australia, 3121 | |
Denmark | |
Medicinsk Afdeling | |
København, Denmark, DK-2100 | |
Nyremedicinsk Afdeling, Medicinerhuset | |
Aalborg, Denmark, DK-9100 | |
Medicinsk Afdeling, nefrologisk, Roskilde Sygehus | |
Roskilde, Denmark, DK-4000 | |
Nefrologisk Afdeling, Hilleroed Sygehus | |
Hilleroed, Denmark, DK 3400 | |
France | |
George Pompidou, European Hospital | |
Paris, France, 75908 | |
Germany | |
Universitätsklinikum Aachen, Medizinsche Klinik II | |
Aachen, Germany, D-52074 | |
Heimdialysezentrum | |
Heidelberg, Germany, D-69115 | |
Nephrologisches Zentrum | |
Villingen-Schwenningen, Germany, D 78054 | |
Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin | |
Solingen, Germany, D 42653 | |
Universitätsklinikum Hamburg Eppendorf | |
Hamburg, Germany, D-20246 | |
KfH Nierenzentrum | |
Nürnberg, Germany, D-90431 | |
United Kingdom, England | |
Renal & Urology SDU Offices | |
London, England, United Kingdom, SE1 9RT | |
Renal Department, The Royal London Hospital | |
London, England, United Kingdom, E1 1BB | |
Department of Renal Medicine, Hope Hospital | |
Manchester, England, United Kingdom, M6 8HD | |
Renal Dialysis Unit, Manchester Royal Infirmary | |
Manchester, England, United Kingdom, M13 9WL | |
Leicester General Hospital | |
Leicester, England, United Kingdom, LE5 4PW | |
Southmead Hospital | |
Bristol, England, United Kingdom, BS10 5NB | |
Birmingham Hospital, Queen Elizabeth Medical Centre | |
Birmingham, England, United Kingdom, B15 2PR | |
Renal Unit, Queen Alexandra Hospital | |
Portsmouth, England, United Kingdom, PO6 3RY | |
Addenbrooke's Dialysis Centre | |
Cambridge, England, United Kingdom, CB2 2QQ |
Study Director: | Luthando Adams, MBChB | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | SVCARB00105, ACTRN012606000380594 |
Study First Received: | May 19, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00681941 |
Health Authority: | United Kingdom: Research Ethics Committee |
Sevelamer Renal Insufficiency Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Hyperphosphatemia Kidney Diseases Metabolic disorder Kidney Failure |
Phosphorus Metabolism Disorders Molecular Mechanisms of Pharmacological Action Chelating Agents Pharmacologic Actions |