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. - ND

• Conditions: Hyperphosphatemia; MedDRA version: 9.1Level: LLTClassification code 10020711Term: Hyperphosphataemia

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

Male or female subjects > or = 18 years of age receiving a stable regimen of haemodialysis for CKD Stage 5 (defined as haemodialysis two or three times per week for at least two months prior to screening). Females of child bearing potential (FOCP) must be non-pregnant, non-lactating, have a negative serum beta human chorionic gonadotropin (HCG) test, and agree to comply with any applicable contraceptive requirements of the protocol. Additionally, subjects on a stable phosphate binder dose (defined as no change in medication or dosage for at least the one month prior to screening) with a serum phosphorus level between >1.78 and 5.5 and 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 parathyroid hormone (iPTH) level >500pg/mL, or a history of previous parathyroidectomy within 12 months of screening. Subjects with any significant bowel obstruction, active inflammatory bowel disease, gastrointestinal (GI) motility disorders, abnormal or irregular bowel motion, or a history of major GI surgery within the last 6 months will be excluded. Furthermore, subjects receiving aluminium, magnesium, or combination therapy other than sevelamer HCl and calcium as a phosphate binder will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified