EUCTR2006-004959-38-DE进行中（未招募）不适用
A prospective multicenter, open-label, randomised, cross-over study to compare the efficacy and safety of Fosrenol and Sevelemer Hydrochloride in patients receiving hemodialysis for end stage renal disease
Shire Development Inc0 个研究点目标入组 214 人开始时间: 2007年4月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 214
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Aged 18 or over
- •Females must be non-pregnant and agree to comply with the contraceptive requirements of the protocol
- •Must have CKD Stage 5 and and have been receiving haemodialysis two times or 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. Treatment-naiive patients are permitted to enter the study providing serum phosphorus levels are greater or equal 6.0 mg/dL (1.92 mmol/L)
- •must understand and be able and willing and likely to fully comply with study procedures and restrictions
- •written, signed and dated informed consent to praticipate in 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
排除标准
- •Patients who require treatment with cinacalcet hydrochloride, or with compounds containing phosphate or 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 (<2.20mmol/L)
- •Life threatening malignancy or current multiple myeloma
- •known to be HIV positive
- •Hypersensitivity to investigational products
- •Alcohol or other substance abuse 1 year prior to screening
- •Patients must not have used another investigational product or taken part in a clinical trial within the last 30 days prior to enrollment
- •Patients who have been officially ordered to be detained in an institution
研究者
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A prospective multicenter, open-label, randomised, cross-over study to compare the efficacy and safety of Fosrenol and Sevelemer Hydrochloride in patients receiving hemodialysis for end stage renal diseaseHyperphosphataemia in patients with end-stage renal disease receiving haemodialysisMedDRA version: 8.1 Level: LLT Classification code 10020712 Term: HyperphosphatemiaEUCTR2006-004959-38-GBShire Development Inc214
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