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TERMINATEDPHASE2

Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)

NCT04001036•Iperboreal Pharma Srl

View on ClinicalTrials.gov

Summary

Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
•Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
•Hemoglobin level ≥ 9g/dL;
•Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
•To understand and sign an informed consent form.

Exclusion Criteria

•History of alcohol or drug abuse in the last six months before selection for the study;
•Androgen therapy in the last six months before selection;
•Active infections;
•History of congestive heart failure stage III and IV New York Heart Association (NYHA);
•History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
•Clinically relevant cardiac arrhythmia;
•Clinically relevant abnormalities of functional hepatic tests;
•Therapy with L-carnitine or its derivatives in the last three months before selection;
•Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
•Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
+2 more criteria

Locations (1)

Department of Nephrology, University of Chieti

Chieti, Italy

Key Dates

Start Date

September 1, 2019

Primary Completion Date

August 30, 2022

Completion Date

August 30, 2022

Last Updated

March 3, 2023

Enrollment

ACTUAL participants

Conditions

End Stage Renal Disease

Interventions

1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine

DRUG

0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine

DRUG

EndoForce Post Approval Study

NCT07146854

End Stage Renal Disease (ESRD)

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RECRUITINGNA

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

NCT04163614

End Stage Renal DiseaseHypertension+2 more

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RECRUITINGPHASE2

Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

Inclusion Criteria

Exclusion Criteria

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Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

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