None listed
Conditions
Brief summary
Carnitine is found in all mammals and is required for energy production. A large proportion of carnitine within the body is obtained from the diet and a lesser amount is made by the kidneys and liver. Carnitine deficiency is common in haemodialysis patients due to their low protein diet and abnormal kidney function, and also because carnitine is easily removed by the dialysis procedure. Carnitine is administered to dialysis patients in the United States and other countries for the treatment of dialysis-related carnitine deficiency. This study is being conducted to investigate the effect of carnitine administration on a number of common problems associated with dialysis, including muscle fatigue, anaemia and symptoms such as muscle cramps.
Interventions
10-20 mg/kg intravenous L-carnitine after each dialysis session for 6 months. Dose will be based on patient dry weight such that patients weighing <50kg will be administered 0.5g L-carnitine; patients weighing 50-100kg will be administered 1g L-carntine; and patients weighing >100kg will be administered 2g L-carnitine. Patients will dialyse, on average, 3 times per week. It is therefore anticipated that, on average, a 50-100kg patient will receive a dose of 3g/week, equating to an overall exposu
10-20 mg/kg intravenous L-carnitine after each dialysis session for 6 months. Dose will be based on patient dry weight such that patients weighing <50kg will be administered 0.5g L-carnitine; patients weighing 50-100kg will be administered 1g L-carntine; and patients weighing >100kg will be administered 2g L-carnitine. Patients will dialyse, on average, 3 times per week. It is therefore anticipated that, on average, a 50-100kg patient will receive a dose of 3g/week, equating to an overall exposure of approximately 78g during the trial.
Sponsors
University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is >18 years of age at the time of informed consent. 2. Patient is a male or non-pregnant, non-lactating female who is considered unlikely to conceive. 3. Patient has been diagnosed with end-stage renal disease and has received haemodialysis treatment for >6 months at the time of the screening evaluation. 4. Patient has a calculated Erythropoietin Resistance Index >0.020 µg/kg/week/g Haemoglobin (Hb) at the screening evaluation. 5. Patient is aware of the study procedures and the risks involved and voluntarily agrees to participate by providing written informed consent.
Exclusion criteria
1. Patient has a history of allergy and/or sensitively to L-carnitine or any carnitine derivatives. 2. Patient has received treatment with L-carnitine or any carnitine derivatives within 2 months of the screening evaluation. 3. Patient has received treatment with a pharmacologic agent, such as valproic acid or pivampicillin, known to alter carnitine homeostasis. 4. Patient has a history of seizure activity. 5. Patient has a history or current evidence of any condition, therapy or laboratory abnormality that, in the opinion of the investigator, might affect the results of the study or may not be in the best interest of the patient to participate. 6. Patient has participated in a clinical trial within 2 months of the screening evaluation that, in the opinion of the investigator, might affect the results of the study or may not be in the best interest of the patient to participate.
Outcome results
None listed