Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine

NCT ID: NCT04086212

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-02
• Study Completion Date: 2023-04-30

Brief Summary

Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD solution for long dwell exchange.

Detailed Description

The use of a solution icodextrin, xylitol and carnitine (IXC) as the osmotic agent in dialysate for the long dwell exchange provides sustained ultrafiltration (UF) through colloid osmosis, allowing a consistent reduction in extracellular fluid volume without the expected fall in urine output. The other major advantage of IXC is the reduced exposure and absorption of glucose as the main osmotic agent in PD therapy. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal IXC-based PD solution. Compared to glucose, indeed, carnitine and xylitol are extremely stable naturally occurring compounds, even at temperatures higher than those used to steam-sterilize infusional product. As a consequence, xylitol and carnitine may represent better alternatives than glucose as an osmotic ingredient both from the manufacturing and biocompatibility standpoints. Moreover, xylitol and carnitine have an excellent safety profile and possess distinct systemic actions, which are more favorable than glucose.

Conditions

End Stage Renal Disease (ESRD)

Study Design

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

Study Groups

IXC Peritoneal dialysis solution

IXC (Icodextrin, Xylitol and L-Carnitine) Peritoneal dialysis solution

Group Type: EXPERIMENTAL

Icodextrin, xylitol and carnitine solution for peritoneal dialysis

Intervention Type: DRUG

Patients will receive a long dwell exchange for three days.

Icodextrin

Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution

Group Type: ACTIVE_COMPARATOR

EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution

Intervention Type: DRUG

Patients will receive a long dwell exchange for three days.

Interventions

Icodextrin, xylitol and carnitine solution for peritoneal dialysis

Patients will receive a long dwell exchange for three days.

Intervention Type: DRUG

EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution

Patients will receive a long dwell exchange for three days.

Intervention Type: DRUG

Other Intervention Names

IXC; icodextrin

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) for at least 3 months
• A stable clinical condition during the two weeks immediately prior to randomization
• Blood hemoglobin concentration above 8,5 g/100ml
• Has not experienced peritonitis episodes in the last 3 months
• Treated with Extraneal for at least 1 month
• Peritoneal Equilibration Test (PET) performed in the last three months
• Has understood and signed the Informed Consent Form.

Exclusion Criteria

• History of drug or alcohol abuse in the six months prior to entering the protocol
• Acute infectious condition
• History of severe congestive heart failure and clinically significant arrhythmia
• Malignancy within the past 5 years, including lymphoproliferative disorders
• A medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug
• A clinically relevant under-hydration as judged by the treating physician
• History of L-Carnitine therapy or use in the month before entering the study
• Received any investigational drug in the 3 months before entering the study
• Pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive measures

• 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, University of Chieti, Italy

Other Identifiers

IP-001-10

Identifier Type: -

Identifier Source: org_study_id