Spironolactone After Liver Transplant

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02883400
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Transplant, Liver	Drug: Spironolactone	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spironolactone to Prevent or Delay Calcineurin Inhibitor (CNI) Toxicity in Liver Transplant Recipients
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: SOC-Standard of care standard of care, nontreatment
Experimental: spironolactone spironolactone	Drug: Spironolactone; spironolactone 25 mg up to 50 mg

Outcome Measures

Primary Outcome Measures

1. Glomerular Filtration Rate (GFR) [18 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• liver transplant

Exclusion Criteria:

• dual organ transplant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHS	Charlotte	North Carolina	United States	28203

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Mark W. Russo, MD, MPH, Charolinas Healthcare System

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 10, 2016

More Information

Publications

• 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.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02883400
• Other Study ID Numbers: 12-14-03A
• First Posted: Aug 30, 2016
• Last Update Posted: Apr 21, 2022
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Spironolactone

Study Results

Participant Flow

Arm/Group Title	SOC-Standard of Care	Spironolactone
Arm/Group Description	standard of care, nontreatment	spironolactone Spironolactone: spironolactone 25 mg up to 50 mg
Period Title: Overall Study
STARTED	22	8
COMPLETED	22	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	SOC-Standard of Care	Spironolactone	Total
Arm/Group Description	standard of care, nontreatment	spironolactone Spironolactone: spironolactone 25 mg up to 50 mg	Total of all reporting groups
Overall Participants	22	8	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 86.4%	8 100%	27 90%
>=65 years	3 13.6%	0 0%	3 10%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	55	55	55
Sex: Female, Male (Count of Participants)
Female	3 13.6%	3 37.5%	6 20%
Male	19 86.4%	5 62.5%	24 80%
Race/Ethnicity, Customized (Count of Participants)
White Non-Hispanic	19 86.4%	8 100%	27 90%
Black or African American	1 4.5%	0 0%	1 3.3%
Hispanic or Latino	2 9.1%	0 0%	2 6.7%
Region of Enrollment (participants) [Number]
United States	22 100%	8 100%	30 100%
Glomerular Filtration Rate (mL/min//1.73m^2) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [mL/min//1.73m^2]	90	90	90

Outcome Measures

1. Primary Outcome

Title	Glomerular Filtration Rate (GFR)
Description	The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

liver transplant recipients

Arm/Group Title	SOC-Standard of Care	Spironolactone
Arm/Group Description	Standard of care	spironolactone group
Measure Participants	22	8
Mean (Inter-Quartile Range) [ml/min/1.73m^2]	69	64

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOC-Standard of Care, Spironolactone
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	18 months
Adverse Event Reporting Description	adverse events were collected according to clinical trials. gov defintions or by clinical descrption
Arm/Group Title	SOC-Standard of Care		Spironolactone
Arm/Group Description	standard of care, nontreatment		spironolactone Spironolactone: spironolactone 25 mg up to 50 mg
All Cause Mortality
	SOC-Standard of Care		Spironolactone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		1/8 (12.5%)
Serious Adverse Events
	SOC-Standard of Care		Spironolactone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/22 (9.1%)		2/8 (25%)
Cardiac disorders
cardiopulmonary arrest	0/22 (0%)	0	1/8 (12.5%)	1
General disorders
Fever	2/22 (9.1%)	2	2/8 (25%)	2
Other (Not Including Serious) Adverse Events
	SOC-Standard of Care		Spironolactone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/22 (4.5%)		3/8 (37.5%)
Blood and lymphatic system disorders
elevated serum potassium	1/22 (4.5%)	1	3/8 (37.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.