Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5
This study has been terminated.
(This study was stopped by the sponsor based on a non-safety related corporate decision)
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00452478
First received: March 23, 2007
Last updated: December 18, 2007
Last verified: December 2007
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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 4 |
| 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 |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78 mmol/L (5.5 mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol [ Time Frame: at Week 2 compared to baseline ] [ Designated as safety issue: No ]
- Biochemical and haematological parameters [ Time Frame: measured throughout the study ] [ Designated as safety issue: No ]
- Assess safety & tolerability [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
| 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 |
Criteria
Inclusion Criteria:
- Male or female subjects greater than or equal to 18 years of age receiving a stable regimen of haemodialysis for chronic kidney disease (CKD) Stage 5 (defined as haemodialysis two or three times per week for at least two months prior to screening).
- Females of child bearing potential (FOCP) must be non-pregnant, non-lactating, have a negative serum beta human chorionic gonadotropin (HCG) test, and agree to comply with any applicable contraceptive requirements of the protocol.
- Subjects on a stable phosphate binder dose (defined as no change in medication or dosage for at least the one month prior to screening) with a serum phosphorus level between greater than 1.78 and less than or equal to 2.43 mmol/L (5.5 and 7.5 mg/dL).
Exclusion Criteria:
- Subjects with a corrected serum calcium level less than 2.1 mmol/L (8.5 mg/dL).
- Subjects with an intact parathyroid hormone (iPTH) level greater than 500 pg/mL, or a history of previous parathyroidectomy within 12 months of screening.
- Subjects with any significant bowel obstruction, active inflammatory bowel disease, gastrointestinal (GI) motility disorders, abnormal or irregular bowel motion, or a history of major GI surgery within the last 6 months will be excluded.
- Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer hydrogen chloride (HCl) and calcium as a phosphate binder at the time of screening will be excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452478
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 | |
Sponsors and Collaborators
Shire Development LLC
Investigators
| Principal Investigator: | Mario Cozzolino, MD, PhD | Renal Physician |
More Information
No publications provided
| 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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 |
Keywords provided by Shire Development LLC:
|
Hyperphosphataemia |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 19, 2013