Clinical trial NCT00851838: L-Carnitine as an Osmo-metabolic Agent for Peritoneal Dialysis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End-Stage Renal Disease
Keywords: Peritoneal dialysis
L-carnitine
ESRD
Lead sponsor: Iperboreal Pharma Srl
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 possibility to formulate PD solutions containing L-carnitine as an osmotic agent to partially replace glucose.


Eligibility 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

Primary outcomes:
measure: To assess the efficacy of L-Carnitine containing PD solution on peritoneal ultrafiltration
timeFrame: day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Division of Nephrology, University of "G. d'Annunzio"
Study officials:
affiliation: G. d'Annunzio University
name: Mario Bonomini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iperboreal Pharma Srl
name: Arduino Arduini, MD
role: STUDY_DIRECTOR
References: