L-Carnitine in Peritoneal Dialysis
Phase 2 Study of Dialysis Efficiency and Tolerability of Nocturnal Peritoneal Dialysis Solution Containing Glucose Plus L-carnitine
  • Phase

    Phase 2
  • Study Type

  • Study Participants

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.
Study Started
Jun 30
Primary Completion
Oct 31
Study Completion
Dec 31
Results Posted
Jun 17
Last Update
Feb 23

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.

Peritoneal Dialysis Solution Experimental


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


Peritoneal Dialysis Solution

All Events

Event Type Organ System Event Term

Long Dwell Ultrafiltration

The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.

Peritoneal Dialysis Solution

milliliters (Mean)
Standard Deviation: 203

Age Continuous

years (Mean)
Standard Deviation: 11.9


milliliters (Mean)
Standard Deviation: 192

Region of Enrollment

Sex: Female, Male

Overall Study

Peritoneal Dialysis Solution