Back to resultsEfficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD
Primary Purpose
End Stage Renal Disease
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
- Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
- Hemoglobin level ≥ 9g/dL;
- Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
- To understand and sign an informed consent form.
Exclusion Criteria:
- History of alcohol or drug abuse in the last six months before selection for the study;
- Androgen therapy in the last six months before selection;
- Active infections;
- History of congestive heart failure stage III and IV New York Heart Association (NYHA);
- History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
- Clinically relevant cardiac arrhythmia;
- Clinically relevant abnormalities of functional hepatic tests;
- Therapy with L-carnitine or its derivatives in the last three months before selection;
- Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
- Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
- Participation in another clinical study within the past month;
- Known allergic reactions to L-carnitine or xylitol.
Sites / Locations
- Department of Nephrology, University of Chieti
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental peritoneal dialysis solution IPX15
Experimental peritoneal dialysis solution IPX07
Arm Description
Patients will receive treatment with the experimental solution for nocturnal (long-dwell) exchange. For daily (short-dwell) exchanges, all patients will continue the 1 to 3 bags of glucose peritoneal dialysis solution as for their pre-randomization prescription.
Patients will receive 1 to 3 daily (short-dwell) exchanges with the experimental solution (the number of exchanges will be based on their pre-randomization prescription). All patients will receive icodextrin for nocturnal (long-dwell) exchange.
Outcomes
Primary Outcome Measures
Daily ultrafiltration volume
Change from baseline
Secondary Outcome Measures
Peritoneal equilibration test
Change from baseline
Weekly total urea Kt/V
Change from baseline
Weekly total creatinine clearance
Change from baseline
Adverse Events
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04001036
Brief Title
Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD
Official Title
Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
prematurely interrupted due to significant difficulties in the completion of the sample size defined by the study protocol
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
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
Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental peritoneal dialysis solution IPX15
Arm Type
Experimental
Arm Description
Patients will receive treatment with the experimental solution for nocturnal (long-dwell) exchange. For daily (short-dwell) exchanges, all patients will continue the 1 to 3 bags of glucose peritoneal dialysis solution as for their pre-randomization prescription.
Arm Title
Experimental peritoneal dialysis solution IPX07
Arm Type
Experimental
Arm Description
Patients will receive 1 to 3 daily (short-dwell) exchanges with the experimental solution (the number of exchanges will be based on their pre-randomization prescription). All patients will receive icodextrin for nocturnal (long-dwell) exchange.
Intervention Type
Drug
Intervention Name(s)
1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
Other Intervention Name(s)
IPX15
Intervention Description
One bag for nocturnal (long-dwell) exchange.
Intervention Type
Drug
Intervention Name(s)
0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
Other Intervention Name(s)
IPX07
Intervention Description
One to three, daily (short-dwell) exchanges
Primary Outcome Measure Information:
Title
Daily ultrafiltration volume
Description
Change from baseline
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Peritoneal equilibration test
Description
Change from baseline
Time Frame
28 days
Title
Weekly total urea Kt/V
Description
Change from baseline
Time Frame
28 days
Title
Weekly total creatinine clearance
Description
Change from baseline
Time Frame
28 days
Title
Adverse Events
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
Hemoglobin level ≥ 9g/dL;
Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
To understand and sign an informed consent form.
Exclusion Criteria:
History of alcohol or drug abuse in the last six months before selection for the study;
Androgen therapy in the last six months before selection;
Active infections;
History of congestive heart failure stage III and IV New York Heart Association (NYHA);
History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
Clinically relevant cardiac arrhythmia;
Clinically relevant abnormalities of functional hepatic tests;
Therapy with L-carnitine or its derivatives in the last three months before selection;
Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
Participation in another clinical study within the past month;
Known allergic reactions to L-carnitine or xylitol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Bonomini, MD
Organizational Affiliation
Institute of Nephrology, G. D'annunzio University, Chieti, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, University of Chieti
City
Chieti
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD
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