drugset / Trial / NCT02883400
Spironolactone After Liver Transplant
RandomizedParallel-groupOpen-labelTreatment
Summary
To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.
Timeline
- Start
- 2014-12
- Primary completion
- 2018-01
- Completion
- 2018-01
Outcome
Missed primary endpoint
registry analysis (superiority test); SOC-Standard of Care vs Spironolactone; p = 0.0001; Mean Difference (Final Values) 5; Wilcoxon (Mann-Whitney) NCT02883400 ↗
Publications
- Background Russo MW, Krista Bossi, Gale Groseclose, Levi DM, Lon Eskind, Bennett Noell, Anderson WE, Zamor PJ, Vincent Casingal. Estimates of Glomerular filtration rate in liver transplant recipients are not accurate: A role for 24 hour urine creatinine clearance. Archives of Transplantation 2018:2:1-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spironolactone | Small molecule | 25 mg | — |
| Subject | Spironolactone | Small molecule | 50 mg | — |