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Trial registered on ANZCTR


Registration number
ACTRN12609000024246
Ethics application status
Approved
Date submitted
14/08/2008
Date registered
12/01/2009
Date last updated
7/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
ACCORD: Assessment of Carnitine for Clinical Outcomes in Renal Disease
Scientific title
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.
Secondary ID [1] 281507 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACCORD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erythropoietin-Resistant Anaemia 3561 0
Condition category
Condition code
Renal and Urogenital 3716 3716 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3274 0
Treatment: Drugs
Comparator / control treatment
Matched placebo (saline solution) administered as an intravenous dose after each dialysis session.
Control group
Placebo

Outcomes
Primary outcome [1] 4621 0
Erythropoietin Resistance Index
Timepoint [1] 4621 0
3 & 6 months
Secondary outcome [1] 7794 0
Skeletal Muscle Fatigue, assessed using a validated hand-grip fatigue test developed in-house.
Timepoint [1] 7794 0
3 & 6 months
Secondary outcome [2] 7795 0
Quality of Life (SF-36)
Timepoint [2] 7795 0
3 & 6 months
Secondary outcome [3] 7796 0
Dialytic Symptoms, assessed using a dialysis symptom 5-point rating scale.
Timepoint [3] 7796 0
3 & 6 months
Secondary outcome [4] 7797 0
Plasma Lipid Profile, assessed using blood analysis.
Timepoint [4] 7797 0
3 & 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to treatment will involve contacting the holder of the master randomsiation schedule. This person will be off-site, will not be involved in study assessments and will have no patient contact.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated to treatment using a simple block randomisation generated using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1111 0
5000

Funding & Sponsors
Funding source category [1] 3738 0
Government body
Name [1] 3738 0
National Health and Medical Research Council
Address [1] 3738 0
GPO Box 1421
Canberra ACT 2601
Country [1] 3738 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 3354 0
Hospital
Name [1] 3354 0
Royal Adelaide Hospital
Address [1] 3354 0
North Terrace
Adelaide SA 5000
Country [1] 3354 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5791 0
Human Research Ethics Committee, University of South Australia
Ethics committee address [1] 5791 0
GPO Box 2471
Adelaide SA 5001
Ethics committee country [1] 5791 0
Australia
Date submitted for ethics approval [1] 5791 0
Approval date [1] 5791 0
25/06/2008
Ethics approval number [1] 5791 0
P104/08
Ethics committee name [2] 6416 0
Royal Adelaide Hospital, Research Ethics Committee
Ethics committee address [2] 6416 0
North Terrace
Adelaide SA 5000
Ethics committee country [2] 6416 0
Australia
Date submitted for ethics approval [2] 6416 0
Approval date [2] 6416 0
22/10/2008
Ethics approval number [2] 6416 0
080819

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28847 0
Address 28847 0
Country 28847 0
Phone 28847 0
Fax 28847 0
Email 28847 0
Contact person for public queries
Name 12004 0
Stephanie Reuter
Address 12004 0
Sansom Institute
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 12004 0
Australia
Phone 12004 0
+61 8 8302 1872
Fax 12004 0
Email 12004 0
stephanie.reuter@unisa.edu.au
Contact person for scientific queries
Name 2932 0
Prof Randall Faull
Address 2932 0
Department of Renal Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 2932 0
Australia
Phone 2932 0
+61 8 8222 5203
Fax 2932 0
Email 2932 0
randall.faull@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary