A Study to Evaluate the Efficacy and Safety of XyloCore, a Glucose Sparing Experimental Solution, for Peritoneal Dialysis (ELIXIR)

Phase 1

• Conditions: End-Stage Kidney Disease; MedDRA version: 21.1Level: LLTClassification code: 10014646Term: End stage renal disease (ESRD) Class: 10038359; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

• Registration Number: CTIS2024-513562-19-00
• Lead Sponsor: Iperboreal Pharma S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-30
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/V urea;Secondary Objective: Evaluate changes in LDL, HDL and total cholesterol, serum triglycerides, HbA1c and insulin, Evaluate changes in hemoglobin and EPO requirements, Evaluate changes in patients’ subjective assessment of fatigue (by Chalder Fatigue Scale), Evaluate changes in Peritoneal Ultrafiltration, Evaluate changes in blood pressure, Evaluate changes in diuresis, Evaluate changes in Residual Kidney Function, Evaluate patients' safety;Primary end point(s): Weekly Kt/V urea (V1, V3, V4, V5)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Glycemic and lipid metabolic parameters: LDL, HDL and total cholesterol, serum triglycerides, insulin (V1, V3, V4, V5);Secondary end point(s):EPO requirements (V1, V3, V5);Secondary end point(s):Patients’ subjective assessment of fatigue (V1, V3, V5);Secondary end point(s):24h peritoneal dialysate analysis: volume, ultrafiltration, urea, creatinine (V1, V3, V4, V5);Secondary end point(s):24h urine analysis: volume, urea, creatinine (V1, V3, V4, V5);Secondary end point(s):Residual Kidney Function (V1, V3, V4, V5);Secondary end point(s):Safety, evaluated by physical examinations, vital signs, laboratory outcomes and adverse events (whole study)