A prospective multicenter, open-label, randomised, cross-over study to compare the efficacy and safety of Fosrenol and Sevelemer Hydrochloride in patients receiving hemodialysis for end stage renal disease

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: EUCTR2006-004959-38-GB

Lead Sponsor: Shire Development Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 214

Inclusion Criteria

Aged 18 or over
Females must be non-pregnant
Must have ESRD and have been receiving haemodialysis three times a week for at least 2 months
Being treated with a monotherapy calcium based phosphate binder or a combination therapy not containing Fosrenol or sevelamer hydrochloride and is sub-optimally controlled with screening serum phosphorus levels of greater or equal 5.6 to less than or equal 7.5 mg/dL. Treatment naiive patients are permitted to enter study providing serum phosphorus levels are greater or equal 6.0 mg/dL (1.92 mmol/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

Patients who require treatment with cinacalcet hydrochloride, or with compounds containing phosphorus, magnesium, aluminium or calcium (except as indicated in section 6.4.1 of the protocol) that are used as a phosphate binder.

Any significant GI surgery or GI disorders (including active, uncontrolled peptic ulcer, Crohns disease, GI bleed in last 6 months, past or present GI malignancy

Cirrhosis or other clinically relevant liver disease

Intact PTH >500 pg/ml

Serum calcium <8.8 mg/dL

Life threatening malignancy or current multiple myeloma

HIV positive

Hypersensitivity to investigational products

Alcohol or substance abuse 1 year prior to screening

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of Fosrenol and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline;<br> Secondary Objective: To assess the following:<br><br> the percentage of patients acheiving KDOQI target for serum phosphorus (3.5-5.5mg/dL) following treatment with Fosrenol and sevelamer hydrochloride<br><br> the percentage of responders, defined as > or = 25% decrease in serum phosphorus from baseline following treatment with Fosrenol and sevelamer hydrochloride<br><br> the effects of Fosrenol and sevelamer hydrochloride on calcium-phosphate product and parathyroid hormone (PTH)<br><br> compliance<br><br> safety and tolerability of Fosrenol and sevelamer hydrochloride<br> ;Primary end point(s): The change from baseline in serum phosphorus levels

Secondary Outcome Measures

Name	Time	Method

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