EUCTR2006-005300-13-IT进行中（未招募）不适用
Efficiency of L-Carnitine-containing Peritoneal Dialysis Solutions for diurnal exchanges in diabetes type 2 CAPD patients with ESRD on glucose metabolism. 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5月9日最近更新:
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 >=18 years
- •2.Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months
- •3.Have Type 2 Diabetes, diagnosed according to American Diabetes Association (fasting glucose >=126 mg/dl and 2 h glucose at OGTT >=200 mg/dl), and treated with multiple daily insulin injection or with HbA1c >=8.5%
- •4.Be in a stable clinical condition during the 4 weeks immediately prior to Run-In Period as demonstrated by medical history, physical examination and laboratory testing
- •5.Have a blood hemoglobin concentration > 8,5 g/100ml
- •6.Have not experienced peritonitis episodes in the last 3 months
- •7.Be treated with nocturnal exchange bag solution with ecodestrine (Extraneal) for at least 1 month
- •8.Be treated with 2 or 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)
- •9.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 Run-In Period
- •10.Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 3 months that should be confirmed at Day 0 of Run-In Period
- •11.Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 3 months that should be confirmed at Day 0 of Run-In Period
- •12.Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 3 months that should be confirmed at Day 0 of Run-In Period
- •13.Be treated by the participating clinical Investigator for a period of at least three months
- •14.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
- •1.Have a history of drug or alcohol abuse in the 6 months prior to entering the protocol
- •2.Type 2 Diabetic patients under oral antidiabetic treatment with HbA1C < 8.5%
- •3.Be in treatment with androgens
- •4.Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)
- •5.Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
- •6.Have a history of severe congestive heart failure and clinically significant arrhythmia
- •7.Have an history of epilepsy or any NCS disease
- •8.Have malignancy within the past 5 years, including lymphoproliferative disorders
- •9.Have any chronic medical condition that, in the judgment of the Investigator, would jeopardize the patient?s safety following exposure to study drug
- •10.Have a history of L-Carnitine (and derivates) treatment or use in the month prior to entering the protocol
- •11.Have used any investigational drug in the 3 months prior to entering the protocol
- •12.Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
研究者
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