CTIS2024-513562-19-00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) - IP-001-18
Iperboreal Pharma S.r.l.0 个研究点目标入组 170 人开始时间: 2024年5月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age =18 years, Diagnosis of ESRD and treated with CAPD in the last 3 months, In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events, Have not experienced peritonitis episodes in the last 3 months, In treatment with Extraneal (nocturnal long-dwell exchange for at least one month), 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), Weekly Kt/V urea measurement > 1.7, Followed-up/treated by the participating clinical Center/Investigator in the last three months, Understanding the nature of the study and providing informed consent to participate in the study
排除标准
- •History of drug or alcohol abuse in the six months prior to entering the protocol, Patients affected by Primary Hyperoxaluria as per known medical history, Patients with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women), Patients with a major cardiovascular event in the last 3 months, Patients with advanced cardiac failure (NYHA 4), Hypersensitivity to any of the constituents of the study IMPs, Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC, Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator, 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, In treatment with androgens, Clinically significant abnormal liver function test (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL), Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low tract urinary infections, renal parenchymal infection, pericarditis, etc), Expected patient’s survival shorter than trial duration, L-Carnitine therapy in the month prior to entering the protocol, Have used any investigational drug in the 3 months prior to entering the protocol, Female patients who are pregnant or breast-feeding, Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception
研究者
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