- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02883400
Spironolactone After Liver Transplant
April 19, 2022 updated by: Wake Forest University Health Sciences
Spironolactone to Prevent or Delay Calcineurin Inhibitor (CNI) Toxicity in Liver Transplant Recipients
To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.
Study Overview
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Charlotte, North Carolina, United States, 28203
- CHS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- liver transplant
Exclusion Criteria:
- dual organ transplant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: SOC-Standard of care
standard of care, nontreatment
|
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Experimental: spironolactone
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spironolactone 25 mg up to 50 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glomerular Filtration Rate (GFR)
Time Frame: 18 months
|
The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark W. Russo, MD, MPH, Charolinas Healthcare System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
August 25, 2016
First Submitted That Met QC Criteria
August 25, 2016
First Posted (Estimate)
August 30, 2016
Study Record Updates
Last Update Posted (Actual)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-14-03A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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