EUCTR2006-003364-64-AT
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperphosphataemia in patients with chronic kidney disease stage 5 receiving haemodialysis
- Sponsor
- Shire Pharmaceutical Development Ltd
- Enrollment
- 760
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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