Trial Outcomes & Findings for Spironolactone After Liver Transplant (NCT NCT02883400)

NCT ID: NCT02883400

Last Updated: 2022-04-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2022-04-21

Participant Flow

Participant milestones

Measure	SOC-Standard of Care standard of care, nontreatment	Spironolactone spironolactone Spironolactone: spironolactone 25 mg up to 50 mg
Overall Study STARTED	22	8
Overall Study COMPLETED	22	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Spironolactone After Liver Transplant

Baseline characteristics by cohort

Measure	SOC-Standard of Care n=22 Participants standard of care, nontreatment	Spironolactone n=8 Participants spironolactone Spironolactone: spironolactone 25 mg up to 50 mg	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants	55 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	8 participants n=7 Participants	30 participants n=5 Participants
Glomerular Filtration Rate	90 mL/min//1.73m^2 n=5 Participants	90 mL/min//1.73m^2 n=7 Participants	90 mL/min//1.73m^2 n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: liver transplant recipients

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

Outcome measures

Measure	SOC-Standard of Care n=22 Participants Standard of care	Spironolactone n=8 Participants spironolactone group
Glomerular Filtration Rate (GFR)	69 ml/min/1.73m^2 Interval 50.0 to 110.0	64 ml/min/1.73m^2 Interval 54.0 to 110.0

Adverse Events

SOC-Standard of Care

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Spironolactone

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	SOC-Standard of Care n=22 participants at risk standard of care, nontreatment	Spironolactone n=8 participants at risk spironolactone Spironolactone: spironolactone 25 mg up to 50 mg
General disorders Fever	9.1% 2/22 • Number of events 2 • 18 months adverse events were collected according to clinical trials. gov defintions or by clinical descrption	25.0% 2/8 • Number of events 2 • 18 months adverse events were collected according to clinical trials. gov defintions or by clinical descrption
Cardiac disorders cardiopulmonary arrest	0.00% 0/22 • 18 months adverse events were collected according to clinical trials. gov defintions or by clinical descrption	12.5% 1/8 • Number of events 1 • 18 months adverse events were collected according to clinical trials. gov defintions or by clinical descrption

Other adverse events

Measure	SOC-Standard of Care n=22 participants at risk standard of care, nontreatment	Spironolactone n=8 participants at risk spironolactone Spironolactone: spironolactone 25 mg up to 50 mg
Blood and lymphatic system disorders elevated serum potassium	4.5% 1/22 • Number of events 1 • 18 months adverse events were collected according to clinical trials. gov defintions or by clinical descrption	37.5% 3/8 • Number of events 3 • 18 months adverse events were collected according to clinical trials. gov defintions or by clinical descrption

Additional Information

Dr. Mark Russo,

Atrium Health

Phone: 704-355-6649

Email: mark.russo@atriumhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place