A double-blind, randomized, placebo-controlled multi-center trial to compare the phosphate lowering efficacy of different doses of SBR759 to placebo

• Conditions: hyperphosphataemia in chronic kidney disease patients on renal replacement therapy; MedDRA version: 12.1Level: LLTClassification code 10020711Term: Hyperphosphataemia

• Registration Number: EUCTR2008-006097-15-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-20
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Men or women of at least 18 years of age willing to provide informed consent.

Patient must be on maintenance renal replacement therapy (i.e. hemodialysis, hemodiafiltration or hemofiltration) 3 times per week for = 3 months and must be treated with a stable dialysis prescription, as defined by no change in material (filter/membrane) and dialysis duration of = 3hoursfor = 4 weeks before screening and planned to be maintained the same throughout the study duration.

Patient has a serum phosphate level = 1.78 mmol/L (= 5.5 mg/dL) and =2.9mmol/L ( =9.0 mg/dL), obtained at a 72-hour post-dialysis interval, from the local laboratory, prior to randomization and study treatment initiation.

Patient must have a Kt/V = 1.2 or urea reduction rate of =60%
Patient must be on a stable phosphate binder dose (i.e. no change in prescribed dose) or not have received phosphate binder therapy for at least 4 weeks prior to screening.
Patient must be on restricted phosphate diet at screening and throughout 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

Patient is on peritoneal dialysis.
Patient has a transplant scheduled during the study.
Patient has an uncontrolled hyperparathyroidism (i.e. intact PTH > 800 pg/mL obtained from central laboratory at screening).
Patient had a parathyroidectomy within 3 months prior to screening or scheduled during the study.
Patient has a clinically significant (e.g. chronic unstable) GI disorder and/or has an history of major gastrointestinal tract surgery (e.g. gastrectomy, extensive bowel resection).
Patient is currently being treated with oral iron.
Patient has a transferrin saturation > 60% at screening, obtained from central lab.
Patient has a clinically significant unstable medical condition (in the opinion of the investigator), other than Chronic Kidney Disease, that could negatively impact adequate study conduct or participation.
Patient has a history of hemochromatosis or serum ferritin >1000ng/mL obtained from central laboratory at screening.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the change from baseline in 72-hour serum phosphate of different doses of SBR759 versus placebo over 4 weeks of treatment.;Secondary Objective: To evaluate changes in serum phosphate during a 2-week random treatment withdrawal period of SBR759 after 4 weeks treatment.<br><br>To evaluate dose-dependent efficacy of SBR759.<br><br>To compare the short-term safety profile and dose-dependent tolerability of SBR759, dosed TID with meals, to that of placebo.<br>;Primary end point(s): The primary efficacy variable is change from baseline in 72-hour serum phosphate at 4 weeks<br>Supportive analyses of primary variable : Investigation of the response across SBR759 doses and with respect to placebo.