Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK-D) Trial: A potential new treatment for kidney disease

Phase 3

Completed

• Conditions: Chronic kidney disease; Urological and Genital Diseases; Chronic kidney disease, stage 3

• Registration Number: ISRCTN44522369
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24886488 protocol

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-28
• Study Completion: 2021-12-31
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1434

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
4. Able and willing (in recruiting GP?s opinion) to comply with all study requirements

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
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified