ACCORD: Assessment of Carnitine for Clinical Outcomes in Renal Disease
- Conditions
- Erythropoietin-Resistant AnaemiaRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12609000024246
- Lead Sponsor
- niversity of South Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Erythropoietin Resistance Index[3 & 6 months]
- Secondary Outcome Measures
Name Time Method Skeletal Muscle Fatigue, assessed using a validated hand-grip fatigue test developed in-house.[3 & 6 months];Quality of Life (SF-36)[3 & 6 months];Dialytic Symptoms, assessed using a dialysis symptom 5-point rating scale.[3 & 6 months];Plasma Lipid Profile, assessed using blood analysis.[3 & 6 months]