SPIREN
Trial question
What is the effect of spironolactone in patients with kidney transplantation?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 180
180 patients (63 female, 117 male)
Inclusion criteria: kidney transplant recipients
Key exclusion criteria: intolerance to spironolactone; CrCl < 30 mL/min; serum potassium ≥ 5.5 mmol/L; resin or digoxine treatment; pregnancy
Interventions
N=90 spironolactone (at a dose of 25 mg/day for 3 months, then 50 mg/day for the rest of the study)
N=90 placebo (matching placebo plus standard therapy for 3 years)
Primary outcome
Reduction in measured glomerular filtration rate at 1 year
6.2
-1.4
6.2 mL/min
4.7 mL/min
3.1 mL/min
1.6 mL/min
0.0 mL/min
-1.6 mL/min
Spironolactone
Placebo
Significant
increase ▲
Significant increase in reduction in measured GFR at 1 year (6.2 mL/min vs. -1.4 mL/min; AD 7.6 mL/min, 95% CI 4.3 to 10.9)
Secondary outcomes
Significant increase in reduction in 24 hour proteinuria at 1 year (0.09 g/day vs. -0.07 g/day; AD 0.16 g/day, 95% CI 0.02 to 0.29)
No significant difference in reduction in fibrosis at 2 years (0.52% vs. 3.08%; AD -2.56%, 95% CI -9.36 to 4.24)
Significant increase in reduction in SBP at 1 year (0.61 mmHg vs. -3.97 mmHg; AD 4.59 mmHg, 95% CI 1.08 to 8.1)
Conclusion
In kidney transplant recipients, spironolactone was not superior to placebo with respect to reduction in measured GFR at 1 year.
Reference
Line A Mortensen, Bente Jespersen, Anne Sophie L Helligsoe et al. Effect of Spironolactone on Kidney Function in Kidney Transplant Recipients (the SPIREN trial): A Randomized Placebo-Controlled Clinical Trial. Clin J Am Soc Nephrol. 2024 Jun 1;19(6):755-766.
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