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

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67
participants needed

40
sponsor

Iperboreal Pharma Srl

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Updated on 24 February 2022

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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 Identifier	NCT04001036
Sponsor	Iperboreal Pharma Srl
Last Modified on	24 February 2022

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