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 个研究点目标入组 2,616 人开始时间: 2013年3月19日最近更新: 2013年4月15日

适应症

试验速览

暂无简介。

•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
•F.1.2.1 Number of subjects for this age range 616
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2000

•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.
•Documented Addisonian crisis and/or on fludrocortisone.
•Documented symptomatic hypotension or baseline systolic blood pressure under 100mmHg.
•Recent acute kidney injury or admission for renal failure.
•ACR > 70 mg/mmol.
•Prescription of medications with known harmful interactions with spironolactone as documented in the British National Formulary including tacrolimus, lithium and cyclosporine.
•Any other significant disease or disorder which, in the opinion of the recruiting GP, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

发起方

niversity of Oxford, Clinical Trials and Research Governance Office