L-Carnitine as an Osmo-Metabolic Agent for Peritoneal Dialysis
Information source: Iperboreal Pharma Srl
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End-Stage Renal Disease
Intervention: L-Carnitine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Iperboreal Pharma Srl Official(s) and/or principal investigator(s):
Mario Bonomini, MD, Principal Investigator, Affiliation: G. d'Annunzio University
Arduino Arduini, MD, Study Director, Affiliation: Iperboreal Pharma Srl
Overall contact:
Luigi Godi, MD, Phone: +39 06 79312131, Email: lgodi@harrison-cro.it
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 possibility to formulate PD solutions containing L-carnitine as an osmotic
agent to partially replace glucose.
Clinical Details
Official title: Phase 2 Study of Dialysis Efficiency and Tolerability of Peritoneal Dialysis Solution Containing Glucose Plus L-Carnitine in APD (Automated Peritoneal Dialysis) Treated Uremic Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess the efficacy of L-Carnitine containing PD solution on peritoneal ultrafiltration
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 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 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
Locations and Contacts
Luigi Godi, MD, Phone: +39 06 79312131, Email: lgodi@harrison-cro.it
Division of Nephrology, University of "G. d'Annunzio", Chieti, Italy; Recruiting
Lorenzo Di Liberato, MD, Phone: +39 0871 357538, Email: l.diliberato@aslchieti.it
Mario Bonomini, MD, Principal Investigator
Lorenzo Di Liberato, MD, Sub-Investigator
Additional Information
Starting date: June 2009
Last updated: June 23, 2009
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