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

NCT04086212 | Withdrawn Phase 2

• 1 other identifier: IP-001-10
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

• Net-ultrafiltration

  Net Ultrafiltration at 10 hours (duration of long dwell), in mL, is defined as the difference between the weight of drained volume and weight of the effluent (fill volume).

  Changes from baseline value at the end of each product administration period (3 days)

Secondary Outcomes (5)

• Sodium removal

  Calculated every day for 3 days during each product administration period.

• Carnitine plasmatic level

  Every day for 3 days during each product administration and during the wash-out period

• Xylitol plasmatic level

  Every day for 3 days during each product administration and during the wash-out period.

• Xylitol absorption

  Every day for 3 days during each product administration

• Adverse Events

  Through study completion, an average of 21 days.

Study Arms (2)

IXC Peritoneal dialysis solution

EXPERIMENTAL

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

Drug: Icodextrin, xylitol and carnitine solution for peritoneal dialysis

Icodextrin

ACTIVE COMPARATOR

Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution

Drug: EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution

Interventions

Icodextrin, xylitol and carnitine solution for peritoneal dialysis DRUG

Patients will receive a long dwell exchange for three days.

Also known as: IXC

IXC Peritoneal dialysis solution

EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution DRUG

Patients will receive a long dwell exchange for three days.

Also known as: icodextrin

Icodextrin

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Iperboreal Pharma Srl: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Icodextrin; Xylitol; Peritoneal Dialysis; Dialysis Solutions

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)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Sugar Alcohols; Alcohols; Organic Chemicals; Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Mario Bonomini, MD

  Institute of Nephrology, University of Chieti, Italy

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized cross-over, controlled, open label.

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 11, 2019
• Study Start: October 2, 2019
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: October 1, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share