Can a single drug dose keep donated kidneys healthier?

NCT ID NCT02495077

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

When a kidney is removed from a donor and stored before transplant, proteins like TNF-alpha can build up and damage the organ. Researchers are testing whether infliximab, a drug that blocks TNF-alpha, given just before transplant surgery along with standard transplant medicines can protect the donated kidney. The trial enrolls about 290 adults receiving a deceased-donor kidney transplant. Doctors will compare kidney function over two years between those who receive infliximab and those who do not.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
infliximab, a drug that blocks the inflammatory protein TNF-alpha
What this could lead to
If it works, a single dose of infliximab before transplant could help donated kidneys last longer and reduce the need for repeat transplants.
What could go wrong
This is a Phase 2 trial, so it may not show a clear benefit. Infliximab suppresses the immune system, which could raise the risk of infections or other complications after transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

290 people

The number who actually took part.

Started

Nov 2015

Finished

Jul 2021

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult (\>18 years of age) male and female recipients (all races and ethnicities) 2. Subject must be able to understand and provide consent 3. Recipients of deceased donor kidney transplants (including re-transplants) 4. Negative crossmatch, actual or virtual, or a PRA of 0% on historic and current sera as determined by each participating study center 5. Donor kidneys from deceased donors and donors after cardiac death (DCD) with Kidney Donor Profile Indices (KDPI) ranging from ≥20 to \<95 6. Female participants of childbearing potential must have a negative pregnancy test upon study entry 7. Subjects must have a negative test result for latent tuberculosis (TB) infection (PPD, QuantiFERON, ELISPOT): * Subjects who have a negative test result for latent TB infection within 1 year of transplant date are eligible for enrollment and no further action is required * Subjects who have a negative test for latent TB infection that is greater than 1 year old are eligible for enrollment but are required to have a repeat test prior to transplantation. Exclusion Criteria: 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol 2. Recipients of living donor transplants 3. Presence of other transplanted solid organ (heart, lung, liver, pancreas, small intestines) or co-transplanted organ 4. Human immunodeficiency virus positive (HIV+) recipients 5. Epstein-Barr virus Immunoglobulin G (EBV IgG) negative recipients 6. Hepatitis B surface antigen positive kidney transplant recipients 7. Hepatitis B core antibody positive kidney transplant recipients 8. Hepatitis B negative kidney transplant recipients that receive transplants from Hepatitis B core antibody positive donor 9. Hepatitis C Virus positive (HCV+) patients who are either untreated or have failed to demonstrate sustained viral remission for more than 12 months after anti-viral treatment 10. Recipients with a previous history of active TB 11. Recipients with a positive test for latent TB infection (PPD, QuantiFERON, ELISPOT), regardless of previous therapy 12. Any severe infection at the time of transplantation. --Note: Severe infection determination will be made by the local site investigator. 13. Severe congestive heart failure (NYHA functional class III or higher) 14. Subjects with a known hypersensitivity to any murine/ mouse proteins 15. Subjects with any history of receiving any anti-tumor necrosis factor (anti- TNF) products 16. Subjects in whom rabbit anti-thymocyte globulin (Thymoglobulin®) or infliximab might not be tolerated 17. Subjects with a white blood cell count less than 3000/mm\^3 18. Subjects with a platelet count less than 100,000/mm\^3 19. Subjects with systolic blood pressure \<100 mm/Hg 20. Subjects with symptomatic orthostatic hypotension or currently requiring Midodrine for blood pressure support 21. Subjects from, or who have traveled, to endemic areas with a history of active histoplasmosis or, with a chest x-ray consistent with previous active histoplasmosis (no serological testing required) : --Endemic regions determined by site based on local standard of care. 22. Subjects currently or formerly residing in regions of the United States that are highly endemic for coccidioidomycosis, and who have a positive serologic test for coccidioidomycosis: --Endemic regions determined by site based on local standard of care. 23. Recipients are excluded if the local site decides to treat the recipient with fluconazole because of diagnosis or suspicion of fungal infection the donor 24. Subjects that receive IVIG treatment within 3 months of transplant or planned intravenous immunoglobulin (IVIG) treatment peri-transplant 25. Use of an investigational agent within 4-weeks prior to study entry.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California, Los Angeles

    Los Angeles, California, 90024, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Manitoba

    Winnipeg, Manitoba, R3A 1R9, Canada

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

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