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

Phase 1

• Conditions: Hyperphosphataemia in patients with end-stage renal disease receiving haemodialysis; MedDRA version: 8.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia

• Registration Number: EUCTR2006-003364-64-GB
• Lead Sponsor: Shire Development Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-05
• Study Completion: 2007-12-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 760

Inclusion Criteria

Aged 18 or over and receiving stable regimen of haemodialysis (three times a week) for CKD (stage 5) for at least 2 months prior to screening.

Females must be non-pregnant and non-lactating.

On a stable phosphate binder dose (no change in medication or dose for one month) 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 <2.2mmol/L (8.8mg/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