Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance) only regimen, in patients with End-Stage Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD), over a 6-month study period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iperboreal Pharma Srl
• Treatments: Dialysis Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Age ≥18 years

• Diagnosed with ESRD and treated with CAPD in the last 3 months

• In a stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events

• Have not experienced peritonitis episodes in the last 3 months

• In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month;

• In treatment with 2 to 3 diurnal exchange bag solution of prescribed Phisioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5% glucose)

• Kt/V urea measurement > 1.7 per week at Baseline Visit

• Followed/treated by the participating clinical Center/Investigator in the last three months

• Understanding the nature of the study and providing their informed consent to participation.

Exclusion Criteria:

• History of drug or alcohol abuse in the six months prior to entering the protocol

• In treatment with androgens

• Clinically significant abnormal liver function test (ɣ-GT > 4 times the upper normal limit)

• Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)

• Expected patient's survival shorter than the trial duration

• History of L-Carnitine therapy or use 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

• Patients affected by Primary Hyperoxaluria as per known medical therapy

• 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)