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
- Conditions
- Hyperphosphataemia in patients with chronic kidney disease stage 5 receiving haemodialysisMedDRA version: 8.1Level: LLTClassification code 10020712Term: Hyperphosphatemia
- Registration Number
- EUCTR2006-003364-64-FR
- Lead Sponsor
- Shire Pharmaceutical Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 760
Aged 18 or over and receiving stable regimen of haemodialysis (two or three times a week for at least two months prior to screening) for CKD (stage 5) .
Females must be non-pregnant and non-lactating.
On a stable phosphate binder dose (no change in medication or dose for one month for at least one month prior to screening) with screening serum phosphorus levels of between 5.6 and 7.5 mg/dL inclusive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects with a corrected serum calcium level <2.1mmol/L (8.5mg/dL).
Subjects with an intact parapthyroid hormone level >500pg/ml or a history of parathyroidectomy within 12 months of screening.
Any significant GI disorders (including bowel obstruction, active, inflammatory bowel disease, GI motility disorders, abnormal or irregular bowel motion, major GI surgery in last 6 months.
Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer HCl and calcium as a phosphate binder.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the percentage of subjects who have serum phosphorus levels controlled to <or= 1.78mmol/L (<or=5.5mg/dl) following treatment with Fosrenol compared to their previous phosphate binder;Primary end point(s): The percentage of subjects acheiving serum phosphorus levels of less than or equal to 1.78mmol/L following treatment with Fosrenol at week 12 compared to treatment with their previous phosphate binder therapy.;Secondary Objective: To assess the following:<br><br>If Fosrenol can maintain serum phosphorus levels in subjects converting to Fosrenol from their previous phosphate binder therapy.<br><br>If Fosrenol can reduce serum phosphorus levels in subjects converting to Fosrenol from their previous phosphate binder therapy.<br><br>To assess the control of serum calcium, serum calcium-phosphorus product and intact parathyroid hormone (iPTH).<br><br>To assess the average dose of Fosrenol.<br><br>To assess the safety and tolerability of Fosrenol
- Secondary Outcome Measures
Name Time Method