CTRI/2010/091/000298Other3 期
A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- ovartis
- 入组人数
- 290
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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