A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo

Novartis8 个研究点分布在 1 个国家目标入组 290 人开始时间: 待定

试验速览

阶段: 3 期
发起方: Novartis
入组人数: 290
试验地点: 8
主要终点: * Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment

Target number of patients from India is 60.Planned FPFV is 10th May 2010.

•1.Men or women of at least 18 years of age 2.Stable maintenance of hemodialysis 3 times per week for 3 months or greater 3.Controlled serum phosphate if under phosphate-binder therapy 4.Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening.

•1.Patients who are on peritoneal dialysis 2.Patients who have a transplant or parathyroidectomy scheduled during the study 3.Clinically significant GI disorder 4.Unstable medical condition other than Chronic Kidney Disease 5.Patient is currently being treated with oral iron 6.History of hemachromatosis, or ferritin > 1000 ng/mL 7.Transferrin saturation > 60% 8.Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply.

* Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment

时间窗: 6 weeks

* Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment(6 weeks)
* Evaluate dose-dependent efficacy of SBR759(6 weeks)
* Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo(6 weeks)

发起方

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