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

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

Registration Number: EUCTR2006-004959-38-DE

Lead Sponsor: Shire Development Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 214

Inclusion Criteria

Aged 18 or over

Females must be non-pregnant and agree to comply with the contraceptive requirements of the protocol

Must have CKD Stage 5 and and have been receiving haemodialysis two times or 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. Treatment-naiive patients are permitted to enter the study providing serum phosphorus levels are greater or equal 6.0 mg/dL (1.92 mmol/L)

must understand and be able and willing and likely to fully comply with study procedures and restrictions

written, signed and dated informed consent to praticipate in the study.
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 phosphate or 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 (<2.20mmol/L)

Life threatening malignancy or current multiple myeloma

known to be HIV positive

Hypersensitivity to investigational products

Alcohol or other substance abuse 1 year prior to screening

Patients must not have used another investigational product or taken part in a clinical trial within the last 30 days prior to enrollment

Patients who have been officially ordered to be detained in an institution

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;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 serum calcium and parathyroid hormone (PTH)<br><br>compliance<br><br>safety and tolerability of Fosrenol and sevelamer hydrochloride;Primary end point(s): The change from baseline in serum phosphorus levels

Secondary Outcome Measures

Name	Time	Method

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