BARACK D
Research type
Research Study
Full title
Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) Trial: a prospective randomised open blinded endpoint trial to determine the effect of aldosterone receptor antagonism on mortality and cardiovascular outcomes in patients with stage 3b chronic kidney disease.
IRAS ID
107072
Contact name
Richard Hobbs
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance Office
Eudract number
2012-002672-13
ISRCTN Number
ISRCTN44522369
Research summary
Summary of Results:
We would like to sincerely thank all participants who took part in this study. Their time, commitment, and valuable contribution made this research possible.
Chronic kidney disease affects around 10% of the global population and is associated with significant risk of progression to end-stage renal disease and vascular events. Aldosterone receptor antagonists such as Spironolactone have shown prognostic benefits in patients with heart failure, but effects on patients with chronic kidney disease are uncertain.
The BARACK-D (Benefits of aldosterone receptor antagonism in chronic kidney disease) trial objectives were to determine the effect of low-dose spironolactone on mortality and cardiovascular outcomes in people with chronic kidney disease stage 3b. The trial was a prospective randomised open blinded end-point trial in three hundred and twenty-nine general practitioner practices throughout the United Kingdom.
Participants meeting the criteria for chronic kidney disease stage 3b according to National Institute for Health and Care Excellence guidelines were recruited. Participants were randomised 1: 1 to receive ether spironolactone 25 mg once daily in addition to standard care, or standard care only.Results: The BARACK-D trial has shown that there was no evidence to support adding low dose spironolactone at 25mg daily in participants. 1434 participants were randomised of the 3022 planned. We showed that there were no differences between the intervention and control groups in terms of effectiveness with the primary combined vascular endpoints, nor with the secondary clinical outcomes, including progression in renal decline. These results were the same whether analysing the total treatment periods or a three year follow-up period as was originally planned. Adverse events were experienced more often and participants were more likely to discontinue treatment in the intervention group. The addition of low dose spironolactone was shown to be not cost-effective.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0114
Date of REC Opinion
9 Apr 2013
REC opinion
Further Information Favourable Opinion