L-Carnitine as an Osmo-metabolic Agent for Peritoneal Dialysis

I

Iperboreal Pharma

Status and phase

Completed
Phase 2

Conditions

End-Stage Renal Disease

Treatments

Drug: L-Carnitine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00851838
IP-001-06

Details and patient eligibility

About

A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing L-carnitine as an osmotic agent to partially replace glucose.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18 years
  • Have a diagnosis of ESRD and have been on Automated Peritoneal Dialysis (glucose 1.5 or 2.5 % w/v) 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
  • 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 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 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

PD solution
Experimental group
Treatment:
Drug: L-Carnitine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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