EUCTR2006-005298-23-IT进行中（未招募）不适用
Efficiency of L-Carnitine-containing Peritoneal Dialysis Solutions for diurnal exchanges in CAPD Patients with ESRD on Glucose and Lipid Metabolisms. Randomized, Parallel Study Compared versus a Standard Glucose Solution 1.5 or 2.5 . - ND
IPERBOREAL PHARMA0 个研究点开始时间: 2007年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Age 8805;18 years 2.Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis CAPD for at least 3 months 3.Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing 4.Have a blood hemoglobin concentration 8,5 g/100ml 5.Have not experienced peritonitis episodes in the last 3 months 6.be treated with nocturnal exchange bag solution with icodesctrine Extraneal for at least 1 month 7.Be treated with 2 or 3 diurnal exchange bag solutions 1.5 or 2.5 glucose and one nocturnal exchange bag solution with icodestrine Extraneal 8.Have Kt/V urea measurement 1.7 per week in a previous test performed within 6 months that should be confirmed at Day 0 of Screening Period 9.Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Day 0 of Screening Period 10.Have a D/P Creatinine ratio at Peritoneal Equilibration Test PET between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Day 0 of Screening Period 11.Have a D/P Glucose ratio at Peritoneal Equilibration Test PET between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Day 0 of Screening Period 12.Be treated by the participating clinical Investigator for a period of at least three months 13.Have understood and signed the Informed Consent Form.
- •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
- •Have a history of drug or alcohol abuse in the 6 months prior to entering the protocol Be in treatment with androgens Have Diabetes Mellitus as defined by the American Diabetes Society, objectively documented by a fasting glucose and HbA1c Have clinically significant abnormal liver function test SGOT, SGPT, and gamma-GT 2 times the upper normal limit Have acute infectious conditions i.e. pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc Have a history of congestive heart failure and clinically significant arrhythmia Have an history of epilepsy or any NCS disease Have malignancy within the past 5 years, including lymphoproliferative disorders Have any chronic medical condition that, in the judgment of the Investigator, would jeopardize the patient s safety following exposure to study drug Have a history of L-Carnitine or derivates treatment or use in the month prior to entering the protocol Have used any investigational drug in the 3 months prior to entering the protocol Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
研究者
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