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. - BARACK D

niversity of Oxford, Clinical Trials and Research Governance Office0 sites2,616 target enrollmentMarch 19, 2013

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: We plan a large pragmatic trial to test the potential for spironolactone to to reduce overall cardiovascular events and death, to delay the decline in renal function, and to improve surrogate markers for vascular disease in people with stage 3b (eGFR 30-44 ml/min/1.73m2)Chronic Kidney Disease.
Sponsor: niversity of Oxford, Clinical Trials and Research Governance Office
Enrollment: 2616
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

March 19, 2013

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Oxford, Clinical Trials and Research Governance Office

•Participant is willing and able to give informed consent for participation in the study.
•Male or Female, aged 18 years or above.
•Evidence of stage 3b CKD using the MDRD equation. This includes patients on the CKD register undergoing annual monitoring who have had 2 or more recent samples in the 3b range. as well as patients with at least two consecutive blood samples within the preceding 12 months (with a minimum of 6 weeks between tests) and no identifiable reason for a temporary reduction in eGFR. Where only one test has been performed and is in the 3b range, GPs will be reminded that standard care suggests a second confirmatory test.
•Able (in the recruiting GP’s opinion) and willing to comply with all study requirements.
•Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
•Willing to provide contact details to the Research Team, for use at any time should the need arise, on trial related matters.
•If the participant is a female of child\-bearing potential, they are willing to ensure effective contraception during the trial period.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes

•Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
•Type 1 diabetes mellitus
•Terminal disease or felt otherwise unsuitable by their GP.
•Chronic heart failure clinical diagnosis or known LVSD with EF\<40%.
•Recent myocardial infarction (within 6 months).
•Alcohol or drug abuse.
•Suspected or known current hazardous or harmful drinking, as defined by an alcohol intake of greater than 42 units every week.
•Suspected or known current substance misuse.
•Documented previous hyperkalaemia not thought to be spurious, or intolerance of spironolactone.
•Serum potassium at baseline over 5 mmol/L.