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Effect of an L-carnitine-containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Iperboreal Pharma Srl
Sponsor:
Information provided by (Responsible Party):
Iperboreal Pharma Srl
ClinicalTrials.gov Identifier:
NCT00755456
First received: September 18, 2008
Last updated: March 25, 2013
Last verified: March 2013

September 18, 2008
March 25, 2013
January 2008
October 2013   (final data collection date for primary outcome measure)
To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp [ Time Frame: time 0, 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00755456 on ClinicalTrials.gov Archive Site
  • To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile [ Time Frame: -2 weeks, time 0, 1 month, 2 months, 3 months, 4 months ] [ Designated as safety issue: No ]
  • To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements) [ Time Frame: -2 weeks, time 0, 2 months, 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of an L-carnitine-containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Phase 2 Study of the Effect of a Peritoneal Dialysis Solution Containing Glucose (1.5%) and L-carnitine (0.1%) on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • End Stage Renal Disease
  • Insulin Resistance
  • Drug: PD solution
    Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchange. PD solutions are instilled for 120 days.
  • Drug: PD solution containing L-carnitine
    Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) and L-carnitine (0.1%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchanges. PD solutions are instilled for 120 days.
  • Active Comparator: A
    Intervention: Drug: PD solution
  • Experimental: B
    Intervention: Drug: PD solution containing L-carnitine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age ≥18 years
  2. Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months
  3. 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
  4. Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
  5. Have not experienced peritonitis episodes in the last 3 months
  6. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
  7. Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)
  8. Have Kt/V urea measurement > 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit
  9. Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
  10. 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
  11. 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
  12. Be treated by the participating clinical Investigator for a period of at least three months
  13. Have understood and signed the Informed Consent Form.

Exclusion Criteria:

  1. Have a history of drug or alcohol abuse in the six months prior to entering the protocol
  2. Be in treatment with androgens
  3. Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations)
  4. Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)
  5. Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
  6. Have a history of congestive heart failure and clinically significant arrhythmia
  7. Have an 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, particularly if patient's life expectancy is less than 1 year
  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
Both
18 Years and older
No
Contact: Luigi Godi, MD +39 06 79312131 lgodi@harrison-cro.it
Italy
 
NCT00755456
IP-002-05
No
Iperboreal Pharma Srl
Iperboreal Pharma Srl
Not Provided
Principal Investigator: Mario Bonomini, MD G. d'Annunzio University
Study Director: Arduino Arduini, MD Iperboreal Pharma Srl
Iperboreal Pharma Srl
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP