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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Carnitine
Pharmaceutical Solutions
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 27, 2014