Status:
COMPLETED
Effect of an L-carnitine-containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Lead Sponsor:
Iperboreal Pharma Srl
Conditions:
End Stage Renal Disease
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity measured by a hyperinsulinemic euglycemic clamp.
Eligibility Criteria
Inclusion
- Age ≥18 years
- Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) 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 Extraneal (nocturnal exchange bag solution) for at least 1 month
- Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00755456
Start Date
January 1 2008
End Date
October 1 2012
Last Update
June 26 2019
Active Locations (12)
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1
Renal and Dialysis, Bari Policlinic Hospital
Bari, Italy, 70124
2
Renal, Dialysis and Transplant Unit, University of Bari
Bari, Italy, 70124
3
Division of Nephrology, University of "G. d'Annunzio"
Chieti, Italy, 66100
4
Nephrologyand Dialysis Unit, Desio Hospital
Desio, Italy, 20100