2024-519366-52-00招募中2 期
Pilot Study to Evaluate Safety and Efficacy of PolyCore, a Ternary Combination of Xylitol, L-Carnitine and Polydextrin, to Treat End-Stage Kidney Disease Patients Starting Peritoneal Dialysis (EXCITE)
Iperboreal Pharma S.r.l.6 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年6月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Adverse Events (during the whole study)
研究概览
简要总结
The primary objective is to evaluate the safety of PolyCore through continuous monitoring of adverse events, vital signs, and laboratory parameters.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adults with End-Stage Kidney Disease
- •Patients in treatment with peritoneal dialysis for less than 6 months (at screening visit) and in stable clinical conditions
- •Patients in incremental PD treatment with 1 daily Icodextrin(7.5%)-based solution and 1 daily glucose (up to 1.5%)-based solution, according the IPD regimens allowed by the study (at screening and baseline visits)
- •Understand the nature and characteristics of the study and give informed consent to participate
- •Weekly Kt/V urea ≥ 1.7
排除标准
- •Episode of peritonitis in the last 3 months
- •Hypersensitivity to any of the components of the study IMPs
- •History of primary hyperoxaluria
- •Patients with acute renal failure
- •Presence of contraindications to the use of Polydextrin-based peritoneal dialysis solutions: allergy to starch-based polymers, maltose or isomaltose intolerance, glycogen storage disease, pre-existing severe lactic acidosis
- •Patients with loss of peritoneal function or extensive adhesions compromising peritoneal function
- •patients with a history of abdominal surgery in the month preceding commencement of therapy, patients with abdominal fistulae, tumors, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, abdominal surface or intra-abdominal cavit
- •Uncorrectable mechanical defects that prevent effective PD or increase the risk of infection.
- •History of oxalate or lactate abnormalities considered clinically significant by the investigator
- •History or evidence of any other medical, neurological, or psychological condition that, in the clinical judgment of the investigator, would place the subject at undue risk of a significant AE or interfere with study assessments during the course of the tri
- •Enrolled in a clinical trial with an investigational product within 1 month before the start of the study
- •Suspected or history of drug and/or alcohol abuse
- •Severe pulmonary, cardiac, or hepatic disease/insufficiency
- •Clinically significant abnormal liver function tests (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)
- •Any type of active malignancy. Patients with excised basal cell carcinoma of the skin may be included
- •Female patients who are pregnant or breastfeeding, or women of childbearing potential who are not using or are refusing to use an adequate contraceptive program
结局指标
主要结局
Adverse Events (during the whole study)
Adverse Events (during the whole study)
Physical Examination (at every visit)
Physical Examination (at every visit)
Vital Signs and body weight (at every visit)
Vital Signs and body weight (at every visit)
Blood chemistry and hematology (at every visit)
Blood chemistry and hematology (at every visit)
24h diuresis analysis (at every visit)
24h diuresis analysis (at every visit)
24h dialysate analysis (at every visit)
24h dialysate analysis (at every visit)
Weekly Kt/V urea (evaluated at every visit)
Weekly Kt/V urea (evaluated at every visit)
Residual kidney function (at every visit)
Residual kidney function (at every visit)
次要结局
- Post-baseline profile of weekly Kt/V urea (at every visit)
- Peritoneal ultrafiltration (at every visit and daily by patient diary)
- Peritoneal and total sodium removal (at every visit)
- Glycemic and lipidic parameters (at every visit)
- Peritoneal clearances: creatinine, phosphate, B2-microglobulin, (at every visit)
- Quality of Life: KDQOL-SF (V2, V4)
- N° of patients who dropped-out from the study for safety and efficacy reasons
研究者
Dr. Arduino Arduini
Scientific
Iperboreal Pharma S.r.l.
研究点 (6)
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