ISRCTN44522369
Completed
Phase 3
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 IIIb chronic kidney disease
niversity of Oxford (UK)0 sites1,434 target enrollmentJune 28, 2013
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic kidney disease
- Sponsor
- niversity of Oxford (UK)
- Enrollment
- 1434
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24886488 protocol
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current participant inclusion criteria as of 17/10/2022:
- •1\. Males and females \>\= 18 years of age
- •2\. Evidence of CKD stage 3b from last 2 recorded blood tests
- •3\. Willing and able to give informed consent for participation in the study
- •4\. Able and willing (in recruiting GP's opinion) to comply with all study requirements
- •5\. Female patients willing to ensure effective contraception for trial period
- •Previous participant inclusion criteria:
- •1\. Males and females \>\= 18 years of age
- •2\. Evidence of CKD stage 3b from last 2 recorded blood tests
- •3\. Female patients willing to ensure effective contraception for trial period
Exclusion Criteria
- •Current participant exclusion criteria as of 17/10/2022:
- •1\. Female patient who is pregnant, lactating or planning pregnancy during the trial
- •2\. Type 1 diabetes mellitus
- •3\. Terminal disease or felt otherwise unsuitable by their physician
- •4\. Chronic heart failure clinical diagnosis or known LVSD with EF\<40%
- •5\. Recent myocardial infarction (within 6 months)
- •6\. Active cancer with less than 1\-year life expectancy or in palliative care
- •7\. Alcohol or drug abuse
- •7\.1\. Suspected or known current hazardous or harmful drinking, as defined by an alcohol intake of greater than 42 units every week
- •7\.2\. Suspected or known current substance misuse
Outcomes
Primary Outcomes
Not specified
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