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

NCT ID: NCT04001036

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-08-30

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental peritoneal dialysis solution IPX15

Patients will receive treatment with the experimental solution for nocturnal (long-dwell) exchange. For daily (short-dwell) exchanges, all patients will continue the 1 to 3 bags of glucose peritoneal dialysis solution as for their pre-randomization prescription.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

One bag for nocturnal (long-dwell) exchange.

Experimental peritoneal dialysis solution IPX07

Patients will receive 1 to 3 daily (short-dwell) exchanges with the experimental solution (the number of exchanges will be based on their pre-randomization prescription). All patients will receive icodextrin for nocturnal (long-dwell) exchange.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

One to three, daily (short-dwell) exchanges

Interventions

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

One bag for nocturnal (long-dwell) exchange.

Intervention Type: DRUG

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

One to three, daily (short-dwell) exchanges

Intervention Type: DRUG

Other Intervention Names

IPX15; IPX07

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iperboreal Pharma Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Bonomini, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Nephrology, G. D'annunzio University, Chieti, Italy

Locations

Department of Nephrology, University of Chieti

Chieti, , Italy

Countries

Italy

References

Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.

Reference Type: DERIVED

PMID: 36472884 (View on PubMed)

Other Identifiers

IP-001-09

Identifier Type: -

Identifier Source: org_study_id