A randomised, double-blind, placebo controlled parallel study to assess the efficacy and safety of L-carnitine for the treatment of dialysis-related disorders in end-stage renal disease patients undergoing long-term haemodialysis treatment.

niversity of South Australia0 个研究点目标入组 60 人开始时间: 2009年1月12日最近更新: 2020年1月13日

试验速览

暂无简介。

•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.

发起方

niversity of South Australia