Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003364-64 | EudraCT Number |
Not provided
Not provided
Not provided
This study was stopped by the sponsor based on a non-safety related corporate decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum carbonate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol | at Week 2 compared to baseline | |
| Biochemical and haematological parameters | measured throughout the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse | Feldkirch Tisis | A-6807 | Austria | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Assess safety & tolerability | Throughout the study |
| Krankenhaus Elisabethinen/Dialysestation |
| Linz |
| A-4010 |
| Austria |
| Ziekenhuis Zuid Oost Limburg | Genk | 3600 | Belgium |
| Frederica Sygehus | Fredericia | 7000 | Denmark |
| Holbaek Sykehus | Holbæk | DK-4300 | Denmark |
| Sygehus Viborg | Viborg | 88 00 | Denmark |
| Dialysezentrum Barmbek | Hamburg | 22297 | Germany |
| Dialysezentrum Heilbronn | Heilbronn | 74076 | Germany |
| Dialyse Leipzig | Leipzig | 04178 | Germany |
| Nephrologisches Zentrum Emsland | Lingen | 49808 | Germany |
| nephrologische Schwerpunktpraxis | Oldenburg | 26127 | Germany |
| diabetologische Schwerpunktpraxis | Villingen-Schwenningen | 78054 | Germany |
| University of Milan, San Paolo Hospital, Renal Division | Milan | Italy |
| Gelre Ziekenhuizen | Apeldoorn | 7334 DZ | Netherlands |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
Not provided
Not provided
Not provided