L-Carnitine in Peritoneal Dialysis
Primary Purpose
End-Stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
L-carnitine
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Peritoneal dialysis, L-carnitine
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Have a diagnosis of End Stage Renal Disease and have been on Continuous Ambulatory Peritoneal Dialysis for at least 3 months
- Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing
- Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
- Have not experienced peritonitis episodes in the last 3 months
- Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (2.5% glucose)
- Have Kt/V urea measurement > 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit
- Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
- Have a D/P Creatinine ratio at Peritoneal Equilibration Test between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit
- Have a D/P Glucose ratio at Peritoneal Equilibration Test between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit
- Be treated by the participating clinical Investigator for a period of at least three months
- Have understood and signed the Informed Consent Form.
Exclusion Criteria:
- Have a history of drug or alcohol abuse in the six months prior to entering the protocol
- Be in treatment with androgens
- Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations)
- Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)
- Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
- Have a history of congestive heart failure and clinically significant arrhythmia
- Have an history of epilepsy or any central nervous system disease
- Have malignancy within the past 5 years, including lymphoproliferative disorders
- Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year
- Have a 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
- Pregnant, lactating, fertility age without protection against pregnancy by adequate contraceptive means
Sites / Locations
- Division of Nephrology, University of "G. d'Annunzio"
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peritoneal Dialysis Solution
Arm Description
Outcomes
Primary Outcome Measures
Long Dwell Ultrafiltration
The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.
Secondary Outcome Measures
Full Information
NCT ID
NCT00922701
First Posted
February 11, 2009
Last Updated
February 16, 2010
Sponsor
Iperboreal Pharma Srl
1. Study Identification
Unique Protocol Identification Number
NCT00922701
Brief Title
L-Carnitine in Peritoneal Dialysis
Official Title
Phase 2 Study of Dialysis Efficiency and Tolerability of Nocturnal Peritoneal Dialysis Solution Containing Glucose Plus L-carnitine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Iperboreal Pharma Srl
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy. The study hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions containing L-carnitine as an osmotic agent to partially replace glucose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
Peritoneal dialysis, L-carnitine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peritoneal Dialysis Solution
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention Description
Instillation of glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the nocturnal exchange. Patients were treated with the experimental peritoneal dialysis solution for 5 days.
Primary Outcome Measure Information:
Title
Long Dwell Ultrafiltration
Description
The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.
Time Frame
day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Have a diagnosis of End Stage Renal Disease and have been on Continuous Ambulatory Peritoneal Dialysis for at least 3 months
Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing
Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
Have not experienced peritonitis episodes in the last 3 months
Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (2.5% glucose)
Have Kt/V urea measurement > 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit
Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
Have a D/P Creatinine ratio at Peritoneal Equilibration Test between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit
Have a D/P Glucose ratio at Peritoneal Equilibration Test between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit
Be treated by the participating clinical Investigator for a period of at least three months
Have understood and signed the Informed Consent Form.
Exclusion Criteria:
Have a history of drug or alcohol abuse in the six months prior to entering the protocol
Be in treatment with androgens
Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations)
Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)
Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
Have a history of congestive heart failure and clinically significant arrhythmia
Have an history of epilepsy or any central nervous system disease
Have malignancy within the past 5 years, including lymphoproliferative disorders
Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year
Have a 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
Pregnant, lactating, fertility age without protection against pregnancy by adequate contraceptive means
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Bonomini, M.D.
Organizational Affiliation
G. d'Annunzio University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arduino Arduini, M.D.
Organizational Affiliation
Iperboreal Pharma Srl
Official's Role
Study Director
Facility Information:
Facility Name
Division of Nephrology, University of "G. d'Annunzio"
City
Chieti
ZIP/Postal Code
66013
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21525850
Citation
Bonomini M, Pandolfi A, Di Liberato L, Di Silvestre S, Cnops Y, Di Tomo P, D'Arezzo M, Monaco MP, Giardinelli A, Di Pietro N, Devuyst O, Arduini A. L-carnitine is an osmotic agent suitable for peritoneal dialysis. Kidney Int. 2011 Sep;80(6):645-54. doi: 10.1038/ki.2011.117. Epub 2011 Apr 27.
Results Reference
derived
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L-Carnitine in Peritoneal Dialysis
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