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

  • STATUS
    Recruiting
  • days left to enroll
    67
  • participants needed
    40
  • sponsor
    Iperboreal Pharma Srl
Updated on 24 February 2022
carnitine
nephropathy
dialysis
peritoneal dialysis solution

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.

Details
Condition End Stage Renal Disease
Treatment 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine, 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
Clinical Study IdentifierNCT04001036
SponsorIperboreal Pharma Srl
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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
Participation in another clinical study within the past month
Known allergic reactions to L-carnitine or xylitol
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