Transplant, LiverPhase 4NCT02883400
Spironolactone After Liver Transplant
A Phase 4 study testing Spironolactone in people with Transplant, Liver, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplant, Liver
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver transplant
Who cannot join
- dual organ transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spironolactone to Prevent or Delay Calcineurin Inhibitor (CNI) Toxicity in Liver Transplant Recipients
To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.
Read the 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.
- Conditions
- Transplant, Liver
- Being tested
- Spironolactone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
spironolactone 25 mg up to 50 mg
| Study group | Role | What they receive |
|---|---|---|
| SOC-Standard of care | No intervention | standard of care, nontreatment |
| spironolactone | Experimental | spironolactone Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate (GFR)
The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startDec 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transplant, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark W. Russo, MD, MPH, Principal investigator, Charolinas Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883400
- Sponsor's protocol ID
- 12-14-03A
- Status last verified
- Jun 2021
- First submitted
- 25 Aug 2016
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spironolactone to Prevent or Delay Calcineurin Inhibitor (CNI) Toxicity in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT02883400
- Acronym / sponsor ID
- 12-14-03A
- Conditions
- Transplant, Liver
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC-Standard of care | No intervention | –standard of care, nontreatment |
| spironolactone | Experimental | Drug: Spironolactonespironolactone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- liver transplant
Key exclusion criteria (1 listed)
- dual organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactonespironolactone 25 mg up to 50 mg | Drug | spironolactone |
Primary outcome
Glomerular Filtration Rate (GFR)
Time frame: 18 months
The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundRusso 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark W. Russo, MD, MPH principal investigator
Charolinas Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone in people with Transplant, Liver, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Filtration Rate (GFR) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.