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

Primary Purpose

End Stage Renal Disease (ESRD)

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Icodextrin, xylitol and carnitine solution for peritoneal dialysis
EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
Sponsored by
Iperboreal Pharma Srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease (ESRD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    IXC Peritoneal dialysis solution

    Icodextrin

    Arm Description

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

    Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Sodium removal
    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
    Carnitine plasmatic level is assessed by chemical analysis of patient's plasma samples.
    Xylitol plasmatic level
    Xylitol plasmatic leve is assessed by chemical analysis of patient's plasma samples.
    Xylitol absorption
    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

    Full Information

    First Posted
    September 2, 2019
    Last Updated
    March 28, 2022
    Sponsor
    Iperboreal Pharma Srl
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04086212
    Brief Title
    Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
    Official Title
    Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Iperboreal Pharma Srl

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Disease (ESRD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Model Description
    Randomized cross-over, controlled, open label.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IXC Peritoneal dialysis solution
    Arm Type
    Experimental
    Arm Description
    IXC (Icodextrin, Xylitol and L-Carnitine) Peritoneal dialysis solution
    Arm Title
    Icodextrin
    Arm Type
    Active Comparator
    Arm Description
    Extraneal® (7.5% Icodextrin) Peritoneal dialysis solution
    Intervention Type
    Drug
    Intervention Name(s)
    Icodextrin, xylitol and carnitine solution for peritoneal dialysis
    Other Intervention Name(s)
    IXC
    Intervention Description
    Patients will receive a long dwell exchange for three days.
    Intervention Type
    Drug
    Intervention Name(s)
    EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution
    Other Intervention Name(s)
    icodextrin
    Intervention Description
    Patients will receive a long dwell exchange for three days.
    Primary Outcome Measure Information:
    Title
    Net-ultrafiltration
    Description
    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).
    Time Frame
    Changes from baseline value at the end of each product administration period (3 days)
    Secondary Outcome Measure Information:
    Title
    Sodium removal
    Description
    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.
    Time Frame
    Calculated every day for 3 days during each product administration period.
    Title
    Carnitine plasmatic level
    Description
    Carnitine plasmatic level is assessed by chemical analysis of patient's plasma samples.
    Time Frame
    Every day for 3 days during each product administration and during the wash-out period
    Title
    Xylitol plasmatic level
    Description
    Xylitol plasmatic leve is assessed by chemical analysis of patient's plasma samples.
    Time Frame
    Every day for 3 days during each product administration and during the wash-out period.
    Title
    Xylitol absorption
    Description
    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.
    Time Frame
    Every day for 3 days during each product administration
    Title
    Adverse Events
    Time Frame
    Through study completion, an average of 21 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arduino Arduini, MD
    Phone
    +39.333.6409595
    Email
    a.arduini@iperboreal.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mario Bonomini, MD
    Organizational Affiliation
    Institute of Nephrology, University of Chieti, Italy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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