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Spironolactone After Liver Transplant

Spironolactone to Prevent or Delay Calcineurin Inhibitor (CNI) Toxicity in Liver Transplant Recipients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02883400
Enrollment
30
Registered
2016-08-30
Start date
2014-12-31
Completion date
2018-01-31
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant, Liver

Brief summary

To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.

Detailed description

The aim of this study is to determine if spironolactone decreases nephrotoxicity from calcineurin inhibitors in liver transplant recipients and to determine the best study of renal function in liver transplant recipients.

Interventions

DRUGSpironolactone

spironolactone 25 mg up to 50 mg

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* liver transplant

Exclusion criteria

* dual organ transplant

Design outcomes

Primary

MeasureTime frameDescription
Glomerular Filtration Rate (GFR)18 monthsThe primary analyses were based on the difference between each estimated GFR measure and iothalamate scan.

Countries

United States

Participant flow

Participants by arm

ArmCount
SOC-Standard of Care
standard of care, nontreatment
22
Spironolactone
spironolactone Spironolactone: spironolactone 25 mg up to 50 mg
8
Total30

Baseline characteristics

CharacteristicSOC-Standard of CareSpironolactoneTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants0 Participants3 Participants
Age, Categorical
Between 18 and 65 years
19 Participants8 Participants27 Participants
Age, Continuous55 years55 years55 years
Glomerular Filtration Rate90 mL/min//1.73m^290 mL/min//1.73m^290 mL/min//1.73m^2
Race/Ethnicity, Customized
Black or African American
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Hispanic or Latino
2 Participants0 Participants2 Participants
Race/Ethnicity, Customized
White Non-Hispanic
19 Participants8 Participants27 Participants
Region of Enrollment
United States
22 participants8 participants30 participants
Sex: Female, Male
Female
3 Participants3 Participants6 Participants
Sex: Female, Male
Male
19 Participants5 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 221 / 8
other
Total, other adverse events
1 / 223 / 8
serious
Total, serious adverse events
2 / 222 / 8

Outcome results

Primary

Glomerular Filtration Rate (GFR)

The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan.

Time frame: 18 months

Population: liver transplant recipients

ArmMeasureValue (MEAN)
SOC-Standard of CareGlomerular Filtration Rate (GFR)69 ml/min/1.73m^2
SpironolactoneGlomerular Filtration Rate (GFR)64 ml/min/1.73m^2
p-value: 0.0001Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026