EUCTR2019-004183-21-DK进行中（未招募）1 期
A Study to Evaluate the EffIcacy and Safety of XyloCore, a Glucose Sparing Experimental Solution, for Peritoneal Dialysis - ELIXIR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
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
- 性别
- All
入选标准
- •Patients who meet all of the following criteria will be enrolled:
- •1.Age = 18 years
- •2.Diagnosed of ESRD and treated with CAPD in the last 3 months
- •3.In a stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events
- •4.Have not experienced peritonitis episodes in the last 3 months
- •5.In treatment with Extraneal (nocturnal long-dwell exchange for at least one month);
- •6.In treatment with 1, 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
- •7.Weekly Kt/V urea measurement > 1.7
- •8.Followed-up/treated by the participating clinical Center/Investigator in the last three months
- •9.Understanding the nature of the study and providing informed consent to participate 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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •Patients who fulfill any of the following criteria will not be enrolled:
- •1. History of drug or alcohol abuse in the six months prior to entering
- •the protocol
- •2. In treatment with androgens
- •3. Clinically significant abnormal liver function test (Gamma-GT and/or
- •AST and/or ALT > 24 UNL; and/or total bilirubin > 3 UNL
- •4. Acute infectious conditions (i.e.: pulmonary infection, acute
- •hepatitis, high or low tract urinary infections, renal parenchymal
- •infection, pericarditis, etc)
- •5. Expected patient's survival shorter than trial duration
- •6. L-Carnitine therapy in the month prior to entering the protocol
- •7. Have used any investigational drug in the 3 months prior to entering
- •the protocol
- •8. Female patients who are pregnant or breast-feeding.
- •9. Female patients of childbearing age (less than 24 months after the
- •last menstrual cycle) who do not use adequate contraception*
- •10. Patients affected by Primary Hyperoxaluria as per known medical
- •11. Patients with serum levels of uric acid > 7.2 mg/dl (male and
- •postmenopausal women) or > 6.0 mg/dl (premenopausal women)
- •12. Patients with a major cardiovascular event in the last 3 months
- •13. Patients with advanced cardiac failure (NYHA 4)
- •14. Hypersensitivity to any of the constituents of the study IMPs.
- •15. Any contraindication to the prescribed Peritoneal Dialysis solutions
- •(for long-dwell and short-dwell exchange) as per each product SmPC.
- •16. Participants with medical history of oxalate or lactate abnormalities
- •considered clinically significant by the investigator.
- •17. History or evidence of any other medical, neurological or
- •psychological condition that would expose the subject to an undue risk
- •of a significant AE or interfere with study assessments during the course
- •of the trial as determined by the clinical judgment of the investigator.
研究者
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