Status:
COMPLETED
L-Carnitine as an Osmo-metabolic Agent for Peritoneal Dialysis
Lead Sponsor:
Iperboreal Pharma Srl
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Have a diagnosis of ESRD and have been on Automated Peritoneal Dialysis (glucose 1.5 or 2.5 % w/v) 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
- 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 (PET) 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 (PET) 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
- 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 NCS 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
- Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00851838
Start Date
June 1 2009
End Date
December 1 2012
Last Update
June 25 2019
Active Locations (1)
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1
Division of Nephrology, University of "G. d'Annunzio"
Chieti, Italy