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L-Carnitine as an Osmo-metabolic Agent for Peritoneal Dialysis

Information source: Iperboreal Pharma Srl
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End-Stage Renal Disease

Intervention: L-Carnitine (Drug)

Phase: Phase 2

Status: Completed

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

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: 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

Division of Nephrology, University of "G. d'Annunzio", Chieti, Italy
Additional Information

Starting date: June 2009
Last updated: March 25, 2013

Page last updated: August 23, 2015

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