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

NCT04001036 | Terminated Phase 2

• 1 other identifier: IP-001-09
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Daily ultrafiltration volume

  Change from baseline

  28 days

Secondary Outcomes (4)

• Peritoneal equilibration test

  28 days

• Weekly total urea Kt/V

  28 days

• Weekly total creatinine clearance

  28 days

• Adverse Events

  2 months

Study Arms (2)

Experimental peritoneal dialysis solution IPX15

EXPERIMENTAL

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.

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

Experimental peritoneal dialysis solution IPX07

EXPERIMENTAL

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.

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

Interventions

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

One bag for nocturnal (long-dwell) exchange.

Also known as: IPX15

Experimental peritoneal dialysis solution IPX15

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

One to three, daily (short-dwell) exchanges

Also known as: IPX07

Experimental peritoneal dialysis solution IPX07

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Iperboreal Pharma Srl: lead

Study Sites (1)

Department of Nephrology, University of Chieti

Chieti, Italy

Location

Related Publications (1)

• 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.

  PMID: 36472884 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Xylitol; Glucose; Carnitine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Hexoses; Monosaccharides; Sugars; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines

Study Officials

• Mario Bonomini, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 27, 2019
• Study Start: September 1, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: March 3, 2023

Record last verified: 2022-08

Locations

IT (1)