| March 23, 2007 |
| December 18, 2007 |
| May 2007 |
| |
| 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 ] |
| Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78mmol/L (5.5mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy. |
| Complete list of historical versions of study NCT00452478 on ClinicalTrials.gov Archive Site |
- 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 ]
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| The maintenance of mean serum phosphorus levels following treatment with 2250mg/day of Fosrenol at Week 2 compared to baseline.Biochemical and haematological parameters will be measured throughout the study. |
| |
| Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5 |
| 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 |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Kidney Diseases |
| Drug: Lanthanum carbonate |
| |
| |
| |
| Terminated |
| 68 |
| December 2007 |
|
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.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria, Belgium, Denmark, Germany, Italy, Netherlands |
| |
| NCT00452478 |
| Timothy Whitaker, M.D., Shire Pharmaceutical |
| SPD405-403 |
| Shire Pharmaceutical Development |
|
| Principal Investigator: |
Mario Cozzolino, MD, PhD |
Renal Physician |
|
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| Shire Pharmaceutical Development |
| December 2007 |
