ISRCTN44522369已完成3 期
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 个研究点目标入组 1,434 人开始时间: 2013年6月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,434
研究概览
简要总结
2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24886488 protocol
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •4. Able and willing (in recruiting GP?s opinion) to comply with all study requirements
排除标准
- •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
- •8. Most recent potassium result >5.5 mmol/L, where not thought to be spurious, or previously raised potassium needing a reduced dose of ACEI/ARB or intolerance to spironolactone
- •9. eGFR >60 ml/min/1.73m2 in the last 6 months and no identifiable reason for a temporary reduction in eGFR
- •10. Serum potassium at baseline over 5 mmol/L
- •11. Documented Addisonian crisis and/or on fludrocortisone
- •12. Documented symptomatic hypotension or baseline systolic blood pressure under 100mmHg
- •13. Recent acute kidney injury or admission for renal failure
- •14. ACR > 70 mg/mmol
- •15. Prescription of medications with known harmful interactions with spironolactone as documented in the British National Formulary including tacrolimus, lithium and cyclosporine
- •16. Any other significant disease or disorder which, in the opinion of the recruiting physician, 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
- •Previous participant exclusion criteria:
- •1. Intolerance to Spironolactone or on any prescription medications known to have harmful interactions with Spironolactone.
- •2. Terminal illness, or other significant medical history deemed unsuitable by GP for this trial.
- •3. Hyperkalaemia; Type 1 diabetes mellitus; Addison?s disease.
- •4. Chronic heart failure; recent myocardial infarction (within 6 months); documented symptomatic hypotension; baseline systolic BP under 100mmHg.
- •5. Recent acute kidney injury or admission for renal failure.
- •6. Alcohol or drug abuse, suspected or known.
- •7. Female patient who is pregnant, lactating or planning pregnancy during course of the trial.
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