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-DK
- Lead Sponsor
- Shire Development Inc
- 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
- Secondary Outcome Measures
Name Time Method