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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00452478 |
The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.
Condition | Intervention | Phase |
---|---|---|
Kidney Diseases |
Drug: Lanthanum carbonate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Open-Label, Multi-Centre Trial Evaluating the Conversion From Standard Phosphate Binder Therapy to Fosrenol® in Chronic Kidney Disease Stage 5 Patients on Haemodialysis |
Enrollment: | 68 |
Study Start Date: | May 2007 |
Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Lanthanum carbonate
2250mg/day starting dose of lanthanum carbonate administered orally, in divided doses, with meals (500mg 750mg and 1000mg strengths)for 2 weeks; dose titration will occur based on serum phosphorus results not to exceed 3000mg/day.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse | |
Feldkirch Tisis, Austria, A-6807 | |
Krankenhaus Elisabethinen/Dialysestation | |
Linz, Austria, A-4010 | |
Belgium | |
Ziekenhuis Zuid Oost Limburg | |
Genk, Belgium, 3600 | |
Denmark | |
Sygehus Viborg | |
Viborg, Denmark, 88 00 | |
Holbaek Sykehus | |
Holbaek, Denmark, DK-4300 | |
Frederica Sygehus | |
Fredericia, Denmark, 7000 | |
Germany | |
nephrologische Schwerpunktpraxis | |
Oldenburg, Germany, 26127 | |
diabetologische Schwerpunktpraxis | |
Villingen-Schwenningen, Germany, 78054 | |
Dialysezentrum Heilbronn | |
Heilbronn, Germany, 74076 | |
Nephrologisches Zentrum Emsland | |
Lingen, Germany, 49808 | |
Dialysezentrum Barmbek | |
Hamburg, Germany, 22297 | |
Dialyse Leipzig | |
Leipzig, Germany, 04178 | |
Italy | |
University of Milan, San Paolo Hospital, Renal Division | |
Milan, Italy | |
Netherlands | |
Gelre Ziekenhuizen | |
Apeldoorn, Netherlands, 7334 DZ |
Principal Investigator: | Mario Cozzolino, MD, PhD | Renal Physician |
Responsible Party: | Shire Pharmaceutical ( Timothy Whitaker, M.D. ) |
Study ID Numbers: | SPD405-403 |
Study First Received: | March 23, 2007 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00452478 History of Changes |
Health Authority: | Austria:AGES-PharmMed LCM; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany:BfArM; Ireland: Irish Medicines Board; Italy: The Italian Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Hyperphosphataemia |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Hyperphosphatemia Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |