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| Sponsor: | Shire Pharmaceutical Development |
|---|---|
| Information provided by: | Shire Pharmaceutical Development |
| ClinicalTrials.gov Identifier: | NCT00452478 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: 1 |
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.
Other Name: FOSRENOL
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| Frederica Sygehus | |
| Fredericia, Denmark, 7000 | |
| Holbaek Sykehus | |
| Holbaek, Denmark, DK-4300 | |
| Sygehus Viborg | |
| Viborg, Denmark, 88 00 | |
| Germany | |
| Dialysezentrum Barmbek | |
| Hamburg, Germany, 22297 | |
| Dialysezentrum Heilbronn | |
| Heilbronn, Germany, 74076 | |
| Dialyse Leipzig | |
| Leipzig, Germany, 04178 | |
| Nephrologisches Zentrum Emsland | |
| Lingen, Germany, 49808 | |
| nephrologische Schwerpunktpraxis | |
| Oldenburg, Germany, 26127 | |
| diabetologische Schwerpunktpraxis | |
| Villingen-Schwenningen, Germany, 78054 | |
| 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 |
More Information
| Responsible Party: | Timothy Whitaker, M.D., Shire Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00452478 History of Changes |
| Other Study ID Numbers: | SPD405-403 |
| Study First Received: | March 23, 2007 |
| Last Updated: | December 18, 2007 |
| 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 |
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |