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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iperboreal Pharma Srl
ClinicalTrials.gov Identifier:
NCT00851838
First received: February 25, 2009
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
End-Stage Renal Disease
Drug: L-Carnitine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Iperboreal Pharma Srl:

Primary Outcome Measures:
  • To assess the efficacy of L-Carnitine containing PD solution on peritoneal ultrafiltration [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: June 2009
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851838

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

No publications provided

Responsible Party: Iperboreal Pharma Srl
ClinicalTrials.gov Identifier: NCT00851838     History of Changes
Other Study ID Numbers: IP-001-06
Study First Received: February 25, 2009
Last Updated: March 25, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Iperboreal Pharma Srl:
Peritoneal dialysis
L-carnitine

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014