Condition category
Circulatory System
Date applied
28/05/2008
Date assigned
26/06/2008
Last edited
14/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dundee.ac.uk

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21719783

Publication citations

  1. 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.

Additional files

Editorial Notes