Utilization of a peritoneal solution containing L-Carnitine as osmotic agent in the treatment of ESRD patients with APD MedDRA version: 6.1 Level: PT Classification code 10038444
Conditions
Interventions
Trade Name: CARNITENE*INIET 5F 5ML 1G/5ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Levocarnitine
CAS Number: 54115-1
Concentration unit: % percent
Concentration type: equal
Conc
Sponsors
IPERBOREAL PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age equal/more 18 years 2. Diagnosis of ESRD treated with nocturnal exchange in APD (glucose 1.36 or 2.27%) from at least 1 month 3. Stable clinical condition in the 4 weeks before the Screening Period evaluated by medical history, physical examination, laboratory parameters of renal function and peritoneal permeability 4. Hemoglobin more 8,5 g/100ml 5. No peritonitis in the previous 3 months 6. To be treated in the experimental site from at least 3 months 7. Signed Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Have a history of drug or alcohol abuse in the six months prior to entering the protocol 2.Treatment with androgens 3.Diabetes Mellitus (according to ADA criteria, documented by a fasting glucose and HbA1c) 4.Clinically significant abnormal liver function test (SGOT/SGPT and gammaGT more than 2 times upper normal limit) 5.Presence of infectious conditions 6.Have a history of congestive heart failure and clinically significant arrhythmia 7.History of epilepsy or any NCS disease 8.Have malignancy within the past 5 years, including lymphoproliferative disorders 9.Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient?s safety following exposure to study drug 10.Have a history of L-Carnitine therapy or use in the month prior to entering the protocol 11.Have used any investigational drug in the 3 months prior to entering the protocol 12.Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy and tolerability of a peritoneal dialysis solution for notturnal exchange containing L-Carnitine in End Stage Renal Disease Patients (ESRD) in Automatised Peritoneal Dialysis (APD);Secondary Objective: 1. weekly Kt/V 2. weekly plasmatic Creatinine Clearance(CrCL) 3. PET Creatinine 4. PET Glucose 5. Diuresis 6. ultrafiltration (UF);Primary end point(s): Efficacy and tolerability of a peritoneal dialysis solution for notturnal exchange containing L-Carnitine in End Stage Renal Disease Patients (ESRD) in Automatised Peritoneal Dialysis (APD) | — |
Countries
Italy
Outcome results
None listed