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

Overview

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.

Full Title of Study: “Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

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.

Interventions

  • Drug: Icodextrin, xylitol and carnitine solution for peritoneal dialysis
    • Patients will receive a long dwell exchange for three days.
  • Drug: EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
    • Patients will receive a long dwell exchange for three days.

Arms, Groups and Cohorts

  • Experimental: IXC Peritoneal dialysis solution
    • IXC (Icodextrin, Xylitol and L-Carnitine) Peritoneal dialysis solution
  • Active Comparator: Icodextrin
    • Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution

Clinical Trial Outcome Measures

Primary Measures

  • Net-ultrafiltration
    • Time Frame: Changes from baseline value at the end of each product administration period (3 days)
    • 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).

Secondary Measures

  • Sodium removal
    • Time Frame: Calculated every day for 3 days during each product administration period.
    • Net sodium removal will be calculated as the difference between the total amount of sodium drained at end of long dwell (10 hours) and its measure value in the dialysate at time 0 before the initial infusion. Sodium will determined by the hospital laboratory.
  • Carnitine plasmatic level
    • Time Frame: Every day for 3 days during each product administration and during the wash-out period
    • Carnitine plasmatic level is assessed by chemical analysis of patient’s plasma samples.
  • Xylitol plasmatic level
    • Time Frame: Every day for 3 days during each product administration and during the wash-out period.
    • Xylitol plasmatic leve is assessed by chemical analysis of patient’s plasma samples.
  • Xylitol absorption
    • Time Frame: Every day for 3 days during each product administration
    • Xilitol absorption is determined by calculating the difference (in grams) between the amount of xylitol (measured by lab analysis) in plasma and the amount of xylitol in the patient’s dialysis solution administered.
  • Adverse Events
    • Time Frame: Through study completion, an average of 21 days.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Iperboreal Pharma Srl
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mario Bonomini, MD, Principal Investigator, Institute of Nephrology, University of Chieti, Italy
  • Overall Contact(s)
    • Arduino Arduini, MD, +39.333.6409595, a.arduini@iperboreal.com

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