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

• ClinicalTrials.gov Identifier: NCT00851838
• Recruitment Status: Completed
• First Posted: February 26, 2009
• Last Update Posted: June 25, 2019
• Sponsor: Iperboreal Pharma Srl
• Information provided by (Responsible Party): Iperboreal Pharma Srl

Study Description

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.

Condition or disease	Intervention/treatment	Phase
End-Stage Renal Disease	Drug: L-Carnitine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2009
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: PD solution	Drug: L-Carnitine; Instillation of glucose-based (1.5 or 2.5 w/v) PD solution containing L-carnitine during the nocturnal exchange in APD treated patients. L-Carnitine (0.1% w/v) is present only in the first 5 Liter APD bag. PD solutions are instilled for 5 days.

Outcome Measures

Primary Outcome Measures :

1. To assess the efficacy of L-Carnitine containing PD solution on peritoneal ultrafiltration [ Time Frame: day 5 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

Division of Nephrology, University of "G. d'Annunzio"

Chieti, Italy

Sponsors and Collaborators

Iperboreal Pharma Srl

Investigators

• Principal Investigator: Mario Bonomini, MD; G. d'Annunzio University
• Study Director: Arduino Arduini, MD; Iperboreal Pharma Srl

More Information

• Responsible Party: Iperboreal Pharma Srl
• ClinicalTrials.gov Identifier: NCT00851838 History of Changes
• Other Study ID Numbers: IP-001-06
• First Posted: February 26, 2009
• Last Update Posted: June 25, 2019
• Last Verified: March 2013

Keywords provided by Iperboreal Pharma Srl:

Peritoneal dialysis; L-carnitine; ESRD

Additional relevant MeSH terms:

Kidney Failure, Chronic; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency