Contact information
Type
Scientific
Primary contact
Dr Michelle Kao
ORCID ID
Contact details
Division of Medicine and Therapeutics
Level 7
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 496440
m.kao@dundee.ac.uk
Additional identifiers
EudraCT number
2007-004760-49
ClinicalTrials.gov number
Protocol/serial number
MK001
Study information
Scientific title
Acronym
Study hypothesis
Patients with chronic kidney disease (CKD) mainly die from cardiovascular-related causes, with a mortality 20 times the risk of a general population. Although all the traditional risk factors are accountable, studies show that oxidative stress makes a particular contribution to the excessive cardiovascular risks. Oxidative stress promotes left ventricular hypertrophy (LVH) and causes endothelial dysfunction. LVH is known to be an independent predictor of cardiovascular events and studies have shown the survival benefits of regressing LVH. Allopurinol has been proven to be a potent antioxidant. Hence, this study looks to see if allopurinol would regress LVH and also improve endothelial dysfunction in patients with CKD.
Ethics approval
Tayside Committee on Medical Research Ethics A. Date of approval: 05/12/2007 (ref: 07/S1401/132)
Study design
Randomised, double-blind, placebo-controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic kidney disease (CKD) and left ventricular hypertrophy (LVH)
Intervention
Allopurinol 300 mg vs placebo once a day orally for 9 months
Intervention type
Drug
Phase
Not Specified
Drug names
allopurinol
Primary outcome measure
Reduction in left ventricular hypertrophy at 9 months
Secondary outcome measures
Reduction in endothelial dysfunction at 9 months
Overall trial start date
15/01/2008
Overall trial end date
31/10/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, age >18 years old and there is no upper age limit
2. Chronic kidney disease, Stage 3 (estimated glomerular filtration rate [GFR] 30-60 ml/min)
3. Echo left ventricular hypertrophy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Known cardiac failure with left ventricular ejection fraction (LVEF) <45%
2. Patients already on allopurinol
3. Patients who have gout
4. Patients with severe hepatic disease
5. Usual contraindications to magnetic resonance imaging (MRI), including any metal implants in the body and severe claustrophobia
6. Current immunosuppressive therapy (e.g., azathioprine, ciclosporin or cyclophosphamide), chlorpropamide, theophylline or 6-mercaptopurine
7. Malignancy or other life threatening disease
8. Pregnancy and lactating women
9. Patients unable to provide informed consent (e.g., learning difficulties)
Recruitment start date
15/01/2008
Recruitment end date
31/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Medicine and Therapeutics
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
R and D Office
University of Dundee
11 Perth Road
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 384664
j.z.houston@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21719783
Publication citations
-
Results
Kao MP, Ang DS, Gandy SJ, Nadir MA, Houston JG, Lang CC, Struthers AD, Allopurinol benefits left ventricular mass and endothelial dysfunction in chronic kidney disease., J. Am. Soc. Nephrol., 2011, 22, 7, 1382-1389, doi: 10.1681/ASN.2010111185.