EUCTR2005-003233-41-DE进行中（未招募）不适用
An open label, dose titration study of sevelamer carbonate tablets dosed three times a day in hyperphosphatemic chronic kidney disease patients not on dialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
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
- •1. Men or women 18 years of age or older
- •2. If currently on phosphate binder(s), willing to stop this and enter a 2 week washout period
- •3. Willing to avoid any intentional changes in diet such as fasting or dieting
- •4. Have the following central laboratory measurement:
- •a) If not taking a phosphate binder, a serum phosphorus measurement = 5.5 mg/dL (1.76 mmol/L) at Screening (Visit 1).
- •b) If taking a phosphate binder at screening, a serum phosphorus measurement > 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0).
- •5. At Screening (Visit 1), have the following central laboratory measurements:
- •a) 25-hydroxyvitamin D >10 ng/mL.
- •b) iPTH = 800 pg/mL
- •6. Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study
- •7. Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons
- •8. Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
- •9. If female and childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or IUDs
- •10. Expecting not to initiate dialysis for the duration of this study
- •11. Considered compliant with phosphate binders (if applicable)
- •12. Willing and able to provide informed consent
- •13. Has not participated in any other investigational drug studies within 30 days prior to enrollment
- •14. Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
- •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
- •1. Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders
- •2. Active ethanol or drug abuse, excluding tobacco use
- •3. Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
- •4. In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
- •5. Pregnant or breast-feeding
- •6. Evidence of active malignancy except for basal cell carcinoma of the skin
- •7. Unable to comply with the requirements of the study
- •8. Known hypersensitivity to sevelamer or any constituents of the study drug
- •9. Any other condition, which in the opinion of the investigator will prohibit the patient’s inclusion in the study
研究者
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