BARACK-D
Trial question
What is the role of spironolactone in patients with stage 3b CKD?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 1372
1372 patients (748 female, 624 male).
Inclusion criteria: adult patients with stage 3b CKD.
Key exclusion criteria: pregnancy or lactation; T1DM; terminal disease; chronic HF or known LV systolic dysfunction; recent MI; active cancer with < 1 year life expectancy or in palliative care; alcohol or drug abuse.
Interventions
N=677 spironolactone (at a dose of 25 mg once daily plus usual care).
N=695 usual care (usual care alone).
Primary outcome
First occurrence of death, hospitalization for heart disease, stroke, heart failure, transient ischemic attack or peripheral arterial disease, or first onset of any condition listed not present at baseline at 3 year follow-up
16.7%
16%
16.7 %
12.5 %
8.3 %
4.2 %
0.0 %
Spironolactone
Usual
care
No significant
difference ↔
No significant difference in first occurrence of death, hospitalization for heart disease, stroke, HF, TIA or peripheral arterial disease, or first onset of any condition listed not present at baseline at 3 year follow-up (16.7% vs. 16%; HR 1.05, 95% CI 0.81 to 1.37).
Secondary outcomes
No significant difference in CVD at 3 years (9.7% vs. 8.8%; HR 1.14, 95% CI 0.8 to 1.61).
No significant difference in death at 3 years (6.2% vs. 5.5%; HR 1.09, 95% CI 0.7 to 1.7).
Significant decrease in eGFR at 3 years (41.7 mL/min/1.73m² vs. 42 mL/min/1.73m²; TE -1.14, 95% CI -1.92 to -0.37).
Safety outcomes
No significant difference in serious adverse events.
Significant differences in hyperkalemia (24.7% vs. 13.4%), hypotension (7.4% vs. 4.7%), adverse events (83.0% vs. 50.7%).
Conclusion
In adult patients with stage 3b CKD, spironolactone was not superior to usual care with respect to first occurrence of death, hospitalization for heart disease, stroke, HF, TIA or peripheral arterial disease, or first onset of any condition listed not present at baseline at 3 year follow-up.
Reference
F D Richard Hobbs, Richard J McManus, Clare J Taylor et al. Low-dose spironolactone and cardiovascular outcomes in moderate stage chronic kidney disease: a randomized controlled trial. Nat Med. 2024 Dec;30(12):3634-3645.
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