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

ovartis Pharma Services AG0 个研究点目标入组 225 人开始时间: 2010年4月20日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•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

•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

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