L-Carnitine in Peritoneal Dialysis

This study has been completed.
Sponsor:
Information provided by:
Iperboreal Pharma Srl
ClinicalTrials.gov Identifier:
NCT00922701
First received: February 11, 2009
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy. The study hypothesis is to evaluate the possibility to formulate peritoneal dialysis 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: Allocation: Non-Randomized
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 Nocturnal Peritoneal Dialysis Solution Containing Glucose Plus L-carnitine

Resource links provided by NLM:


Further study details as provided by Iperboreal Pharma Srl:

Primary Outcome Measures:
  • Long Dwell Ultrafiltration [ Time Frame: day 5 ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: June 2004
Study Completion Date: December 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peritoneal Dialysis Solution Drug: L-carnitine
Instillation of glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the nocturnal exchange. Patients were treated with the experimental peritoneal dialysis solution 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 End Stage Renal Disease and have been on Continuous Ambulatory Peritoneal Dialysis 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
  • Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (2.5% glucose)
  • 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 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 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 central nervous system 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
  • Pregnant, lactating, 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: NCT00922701

Locations
Italy
Division of Nephrology, University of "G. d'Annunzio"
Chieti, Italy, 66013
Sponsors and Collaborators
Iperboreal Pharma Srl
Investigators
Principal Investigator: Mario Bonomini, M.D. G. d'Annunzio University
Study Director: Arduino Arduini, M.D. Iperboreal Pharma Srl
  More Information

No publications provided by Iperboreal Pharma Srl

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arduino Arduini, MD, Iperboreal Pharma Srl
ClinicalTrials.gov Identifier: NCT00922701     History of Changes
Other Study ID Numbers: IP-001-04
Study First Received: February 11, 2009
Results First Received: February 11, 2009
Last Updated: February 16, 2010
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
Dialysis Solutions
Pharmaceutical Solutions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014