Effect of Spironolactone on Kidney Function in Kidney Transplant Recipients: A Randomized Placebo-Controlled Clinical Trial.
Mortensen, L. A., et al.Clinical Journal of The American Society of Nephrology: CJASN 2024 [record in progress].
Aims
This study aimed to determine whether spironolactone was effective in stabilising kidney function and reducing glomerular barrier injury among renal transplant recipients treated with calcineurin inhibitors.
Interventions
Participants were randomised to receive either spironolactone or placebo.
Participants
180 kidney transplant recipients.
Outcomes
The primary endpoint was change in measured glomerular filtration rate (GFR). Secondary endpoints included kidney allograft fibrosis, 24-hour proteinuria, and cardiovascular events.
Follow-up
3 years
CET Conclusions
This multicentre, double-blind randomised controlled trial investigated the use of spironolactone in renal transplant recipients, testing the hypothesis that it would reduce progression of fibrosis and functional decline in patients receiving calcineurin inhibitors. 188 participants were followed for 3 years. Contrary to the study hypothesis, the spironolactone group demonstrated a small but sustained reduction in measured GFR compared to controls, with no differences in degree of fibrosis or proteinuria seen. The difference in GFR appears to occur rapidly after initiation of spironolactone, suggesting that it relates to hydration or blood pressure. The study is well designed, with adequate randomisation and allocation concealment as well as double-blind of treatment using placebo. Not all patients underwent biopsy – it is not clear from the manuscript whether this subgroup was self-selected or selected in another way. Overall, this is a robust study that suggests, at least over the 3-yaer timeframe studied, that spironolactone offers no benefit for unselected renal transplant recipients.
Data analysis
Strict intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT01602861; EudraCT - 2011-002243-98