Hyperphosphataemia in patients with end-stage renal disease receiving haemodialysis MedDRA version: 8.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia
Conditions
Sponsors
Shire Development Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: the percentage of patients acheiving KDOQI target for serum phosphorus (3.5-5.5mg/dL) following treatment with Fosrenol and sevelamer hydrochloride the percentage of responders, defined as > or = 25% decrease in serum phosphorus from baseline following treatment with Fosrenol and sevelamer hydrochloride the effects of Fosrenol and sevelamer hydrochloride on calcium-phosphate product and parathyroid hormone (PTH) compliance safety and tolerability of Fosrenol and sevelamer hydrochloride ;Primary end point(s): The change from baseline in serum phosphorus levels | — |
Countries
Germany, United Kingdom
Outcome results
None listed