L-Carnitine in Peritoneal Dialysis
Condition: End-Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: L-carnitine
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peritoneal dialysis; L-carnitine

Summary:

      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.
    

Eligibility 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