Clinical trial NCT04001036: Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: Iperboreal Pharma Srl
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Daily ultrafiltration volume
timeFrame: 28 days
Secondary outcomes:
measure: Peritoneal equilibration test
timeFrame: 28 days
measure: Weekly total urea Kt/V
timeFrame: 28 days
measure: Weekly total creatinine clearance
timeFrame: 28 days
measure: Adverse Events
timeFrame: 2 months
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Department of Nephrology, University of Chieti
Study officials:
affiliation: Institute of Nephrology, G. D'annunzio University, Chieti, Italy
name: Mario Bonomini, MD
role: PRINCIPAL_INVESTIGATOR
References: