A study to evaluate the efficacy and safety of XyloCore, a glucose-sparing experimental solution, for peritoneal dialysis

Sintesi Research0 个研究点目标入组 170 人开始时间: 2022年4月28日最近更新: 2023年11月6日

研究概览

暂无简介。

•1. Age =18 years
•2. Diagnosed with end-stage renal disease (ESRD) and treated with continuous ambulatory peritoneal dialysis (CAPD) in the last 3 months
•3. In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events
•4. Have not experienced peritonitis episodes in the last 3 months
•5. In treatment with prescribed Extraneal (nocturnal long-dwell exchange) for at least 1 month
•6. In treatment with 2 or 3 diurnal short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal, Dianeal low calcium (1.36%, 2.27% or 3.86% glucose), Balance, Bivavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
•7. Weekly Kt/V urea measurement =1.7 (See Annex 1)
•8. Followed/treated by the participating clinical Center/Investigator in the last 3 months
•9. Understanding the nature of the study and providing their informed consent to participate in the study

•1. History of drug or alcohol abuse in the 6 months prior to entering the protocol
•2. In treatment with androgens
•3. Clinically significant abnormal liver function test (Gamma-GT >4 times the upper normal limit)
•4. Acute infectious conditions (i.e. pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
•5. Expected patient’s survival shorter than the 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 breastfeeding
•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 history
•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)

发起方

Sintesi Research