EUCTR2006-003364-64-FI
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
Shire Development Inc0 sites760 target enrollmentSeptember 7, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperphosphataemia in patients with chronic kidney disease stage 5 receiving haemodialysis
- Sponsor
- Shire Development Inc
- 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 at least one month prior to screening) with screening serum phosphorus levels of between 1\.78\-2\.43mmol/L.
- •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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