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

End Stage Renal Disease Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04001036
• Other study ID #: IP-001-09
• Status: Terminated
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2022
• Source: Iperboreal Pharma Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
One bag for nocturnal (long-dwell) exchange.
• 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
One to three, daily (short-dwell) exchanges

Locations

Country	Name	City	State
Italy	Department of Nephrology, University of Chieti	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
Iperboreal Pharma Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily ultrafiltration volume	Change from baseline	28 days
Secondary	Peritoneal equilibration test	Change from baseline	28 days
Secondary	Weekly total urea Kt/V	Change from baseline	28 days
Secondary	Weekly total creatinine clearance	Change from baseline	28 days
Secondary	Adverse Events	Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate.	2 months