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Efficacy and Safety of XyloCore Peritoneal Dialysis Solution. (Elixir)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994471
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Iperboreal Pharma Srl

Brief Summary:
Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance) only regimen, in patients with End-Stage Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD), over a 6-month study period.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght Drug: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution Phase 3

Detailed Description:
Patients should be enrolled if they are receiving 2 or 3 diurnal (short dwell) exchange bag solution of Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5% glucose) and Extraneal (7.5% Icodextrin) for the long-dwell exchange. Patients will be centrally randomized to receive the investigational product (XyloCore) or the active control (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance). A stratified randomization scheme will be employed to ensure a balanced allocation of patients with diabetes across the two treatment groups. Patients randomized to XyloCore will receive 2 to 3 bags of XyloCore (Low, Medium or High Strenght) with an osmotic strength comparable to their pre‐randomization prescription of the glucose peritoneal dialysis solution. Patients randomized to the control group will continue the 2 to 3 daily (short-dwell) exchanges of Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance. All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange. The osmotic strength and number of diurnally short dwells exchanges should be modified by the investigator as clinically required. PD prescriptions in both treatment arms are tailored to reach a minimum target of total Kt/V of 1.7 per week throughout the study. The study will be single-blinded (outcomes assessor), without blinding of patients or clinical staff.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization will be performed centrally via a web-based system, with stratification according to the presence or absence of diabetes.
Masking: Single (Outcomes Assessor)
Masking Description: The study cannot be blinded. The assessment of the primary end-point will be performed by a blinded, third party, independent assessor.
Primary Purpose: Treatment
Official Title: A Study to EvaLuate the EffIcacy and Safety of XyloCore, a Glucose SparIng ExpeRimental Solution, for Peritoneal Dialysis
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XyloCore peritoneal dialysis solution
Patients will receive 2 to 3 daily (short-dwell) exchanges with XyloCore of an osmotic strength comparable to their pre‐randomization prescription of glucose peritoneal dialysis solution (XyloCore Low, Medium and High Strenght have an osmotic strength comparable to Physioneal, Fixioneal or Dianeal 1.36%, 2.27%, 3.86% glucose, respectively, and Balance, Bicavera, Bicanova or Equibalance with 1.5%, 2.5%, 4.25% glucose, respectively). All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.
Drug: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght
XyloCore Low Strenght: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore Medium Strenght: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore High Strenght: 2.0% Xylitol, 1.5% Glucose, and 0.02% L-carnitine
Other Name: XyloCore 0.7 or 1.5 or 2.0

Active Comparator: Glucose peritoneal dialysis solution
Patients randomized to glucose solution will continue the 2 to 3 daily (short-dwell) exchanges of Physioneal 40 or 35, Fixioneal 40 or 35 or Dianeal (1.36%, 2.27%, 3.86% glucose), Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.5%, 4.25% glucose) with the same osmotic strength of their pre‐randomization prescription. All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.
Drug: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium have 1.36%, 2.27% or 3.86% glucose; Balance, Bicavera, Bicanova or Equibalance have 1.25%, 2.3%, 4.5% glucose.
Other Name: Physioneal 40 or 35, Fixioneal 40 or 35, Dianeal, Balance, Bicavera, Bicanova, Equibalance




Primary Outcome Measures :
  1. Total weekly Kt/Vurea [ Time Frame: 24-week ]
    To measure solutes and calculate peritoneal and renal Kt/V (summing up to total Kt/V), dialysate outflow and urine covering 24 hours will be collected, the volumes will be determined, and a blood sample will be taken


Secondary Outcome Measures :
  1. Changes in HbA1c (glycated haemoglobin) [ Time Frame: 6 months ]
    Change from baseline value

  2. Insulin [ Time Frame: 6 months ]
    Changes from the baseline value

  3. LDL cholesterol [ Time Frame: 6 months ]
    Changes from the baseline value

  4. HDL cholesterol [ Time Frame: 6 months ]
    Change from the baseline value

  5. Serum triglycerides [ Time Frame: 6 months ]
    Change from the baseline value

  6. Total cholesterol [ Time Frame: 6 months ]
    Changes from the baseline

  7. Hemoglobin [ Time Frame: 6 months ]
    Changes from the baseline value

  8. EPO requirements [ Time Frame: 6 months ]
    Change from the baseline

  9. Fatigue measured through a validated instrument [ Time Frame: 6 months ]
    Changes from the baseline

  10. Peritoneal ultrafiltration [ Time Frame: 6 months ]
    Changes from baseline

  11. Diuresis (or 24 hours urinary volume) [ Time Frame: 6 months ]
    Changes from baseline

  12. Residual renal function [ Time Frame: 6 months ]
    Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance

  13. Adverse Events [ Time Frame: 6 months ]
    Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosed with ESRD and treated with CAPD in the last 3 months
  • In a stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events
  • Have not experienced peritonitis episodes in the last 3 months
  • In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month;
  • In treatment with 2 to 3 diurnal exchange bag solution of prescribed Phisioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5% glucose)
  • Kt/V urea measurement > 1.7 per week at Baseline Visit
  • Followed/treated by the participating clinical Center/Investigator in the last three months
  • Understanding the nature of the study and providing their informed consent to participation.

Exclusion Criteria:

  • History of drug or alcohol abuse in the six months prior to entering the protocol
  • In treatment with androgens
  • Clinically significant abnormal liver function test (ɣ-GT > 4 times the upper normal limit)
  • Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
  • Expected patient's survival shorter than the trial duration
  • History of L-Carnitine therapy or use in the month prior to entering the protocol
  • Have used any investigational drug in the 3 months prior to entering the protocol
  • Female patients who are pregnant or breast-feeding.
  • Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception
  • Patients affected by Primary Hyperoxaluria, including carrier heterozygous
  • Patients with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women)
  • Patients with a major cardiovascular event in the last 3 months
  • Patients with advanced cardiac failure (NYHA 4)
  • Patients with advanced COPD, characterized by GOLD Guidelines class 3, severe (FEV1/FVC ˂ 0.70; 30% ≤ FEV1 ˂50% predicted) and class 4, very severe (FEV1/FVC ˂ 0.70; FEV1 ˂30% predicted or FEV1 ˂ 50% predicted plus chronic respiratory failure)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994471


Contacts
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Contact: Arduino Arduini, MD +39.333.6409595 a.arduini@iperboreal.com

Locations
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Germany
MVZ DaVita Rhein-Ruhr GmbH
Düsseldorf, Germany, D-40210
Contact: Werner Kleophas, MD       werner.kleophas@davita-dialyse.de   
Italy
Department of Nephrology, University of Chieti
Chieti, Italy
Contact: Mario Bonomini, MD       mario.bonomini@unich.it   
Sponsors and Collaborators
Iperboreal Pharma Srl
Investigators
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Study Director: Arduino Arduini, MD Iperboreal Pharma
Study Chair: Werner Kleophas, MD DaVita Deutschland AG
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Responsible Party: Iperboreal Pharma Srl
ClinicalTrials.gov Identifier: NCT03994471    
Other Study ID Numbers: IP-001-18
2019-004183-21 ( EudraCT Number )
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency