2024-513562-19-00招募中3 期
A Study to Evaluate the Efficacy and Safety of XyloCore, a Glucose Sparing Experimental Solution, for Peritoneal Dialysis (ELIXIR)
Iperboreal Pharma S.r.l.43 个研究点 分布在 5 个国家目标入组 155 人开始时间: 2024年7月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 155
- 试验地点
- 43
- 主要终点
- Weekly Kt/V urea (V1, V3, V4, V5)
研究概览
简要总结
To demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/V urea
研究设计
- 分配方式
- Randomized
- 主要目的
- After-treatment Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 affected by gout, who have had one or more flares of gout during the last 12 months before the screening, 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
结局指标
主要结局
Weekly Kt/V urea (V1, V3, V4, V5)
Weekly Kt/V urea (V1, V3, V4, V5)
次要结局
- Glycemic and lipid metabolic parameters: LDL, HDL and total cholesterol, serum triglycerides, insulin (V1, V3, V4, V5)
- Patients’ subjective assessment of fatigue (V1, V3, V5)
- EPO requirements (V1, V3, V5)
- 24h peritoneal dialysate analysis: volume, ultrafiltration, urea, creatinine (V1, V3, V4, V5)
- 24h urine analysis: volume, urea, creatinine (V1, V3, V4, V5)
- Residual Kidney Function (V1, V3, V4, V5)
- Safety, evaluated by physical examinations, vital signs, laboratory outcomes and adverse events (whole study)
研究者
Arduino Arduini
Scientific
Iperboreal Pharma S.r.l.
研究点 (43)
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