NCT02883400

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

June 29, 2021

Completed
Last Updated

April 21, 2022

Status Verified

June 1, 2021

Enrollment Period

3.1 years

First QC Date

August 25, 2016

Results QC Date

January 21, 2019

Last Update Submit

April 19, 2022

Conditions

Transplant, Liver

Outcome Measures

Primary Outcomes (1)

  • Glomerular Filtration Rate (GFR)

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

    18 months

Study Arms (2)

SOC-Standard of care

NO INTERVENTION

standard of care, nontreatment

spironolactone

EXPERIMENTAL

spironolactone

Drug: Spironolactone

Interventions

SpironolactoneDRUG

spironolactone 25 mg up to 50 mg

spironolactone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver transplant

You may not qualify if:

  • dual organ transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHS

Charlotte, North Carolina, 28203, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Mark Russo,
Organization
Atrium Health
mark.russo@atriumhealth.org
704-355-6649

Study Officials

  • Mark W. Russo, MD, MPH

    Charolinas Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

December 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

April 21, 2022

Results First Posted

June 29, 2021

Record last verified: 2021-06

Locations

US(1)