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Steroid showdown: trial aims to perfect rejection treatment for kidney transplants

NCT ID NCT06474273

Disease control Sponsor: University of Sydney Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

After a kidney or kidney-pancreas transplant, the body may attack the new organ—a problem called acute T cell mediated rejection. Doctors use strong steroids to stop this, but there's no standard dose, and too much can cause serious side effects. This phase 3 trial will enroll 540 participants to compare different steroid doses, aiming to find the safest and most effective approach to treat rejection and protect the transplant.

What this could mean

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

Active substance
Methylprednisolone and prednisone (steroids)
What this could lead to
If successful, this study could establish a standard, safer steroid dosing regimen for treating acute rejection in kidney and kidney-pancreas transplant recipients, reducing side effects while preserving organ function.
What could go wrong
This is a phase 3 trial, but it focuses on optimizing an existing treatment rather than a new breakthrough. The optimal dose may still carry significant side effects, and results may not apply to all patient groups.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

2 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: * Participants or their legal guardian must be able to understand and provide written informed consent; * Stated willingness to comply with all study procedures and availability for the duration of the study; * All ethnic and gender groups will have equal access to the study; * All children (aged 2+ years) and adults who have received a kidney or SPK transplant with biopsy proven \*acute TCMR (≥ Banff borderline (minimum i1 score) whether clinical or subclinical). * Individuals with the following are eligible for inclusion: i. Concurrent acute TCMR and microvascular inflammation (MVI) defined as g+ptc, but without ABMR diagnosis. ii. Concurrent acute TCMR and chronic active TCMR. Exclusion Criteria: Individuals meeting any of the following criteria will be excluded from participation: * Mixed rejection. * Active or chronic active ABMR. * Chronic active TCMR. * Isolated v1 without inflammation. * Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus nephropathy. * Active malignancies or active infection that preclude immunosuppression augmentation. * Use of other immunomodulatory agents, including, but not limited to, Rituximab, Anti-TNF monoclonal antibody, Belatacept, Abatacept, Janus kinase inhibitors, Eculizumab, Pegcetacoplan. * Enrolment in other interventional drug trials. * Use of other investigational agents. * Unable to adhere to the study protocol.

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Conditions

The condition(s) this trial relates to.

acute transplant rejection Rejection, Psychology transplant rejection

As listed by the trial registrant

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

Rejection; transplant, kidney Rejection; transplant, pancreas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alberta Children's Hospital

    NOT_YET_RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Auckland City Hospital

    NOT_YET_RECRUITING

    Grafton, Auckland, 1023, New Zealand

  • BC Children's Hospital

    NOT_YET_RECRUITING

    Vancouver, British Columbia, T6G 1C9, Canada

  • CHU Ste-Justine

    NOT_YET_RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • CHU de Quebec

    NOT_YET_RECRUITING

    Québec, Quebec, G1R 2J6, Canada

  • Centre Hospitalier de l'université de Montréal (CHUM)

    NOT_YET_RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Fiona Stanley Hospital

    NOT_YET_RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Foothills Medical Centre

    NOT_YET_RECRUITING

    Calgary, Alberta, T2N 4Z6, Canada

  • Glen Site

    NOT_YET_RECRUITING

    Montreal, Quebec, H3J 0A9, Canada

  • HSC Winnipeg Children's

    NOT_YET_RECRUITING

    Winnipeg, Manitoba, R3A 1R9, Canada

  • Health Sciences Center, University of Manitoba

    NOT_YET_RECRUITING

    Winnipeg, Manitoba, Canada

  • John Hunter Hospital

    NOT_YET_RECRUITING

    Lambton, New South Wales, 2305, Australia

  • London Health Science Centre

    NOT_YET_RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Monash Medical Centre

    NOT_YET_RECRUITING

    Clayton, Victoria, 3168, Australia

  • Montreal Children's Hospital

    NOT_YET_RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Prince of Wales Hospital

    NOT_YET_RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Princess Alexandra Hospital

    NOT_YET_RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • QEII Health Sciences Centre, Nova Scotia Health Authority

    NOT_YET_RECRUITING

    Halifax, Nova Scotia, B3H 1V8, Canada

  • Queensland Children's Hospital

    RECRUITING

    South Brisbane, Queensland, 2014, Australia

  • Royal Adelaide Hospital

    NOT_YET_RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Perth Children's hospital

    NOT_YET_RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Sir Charles Gairdner Hospital

    NOT_YET_RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • St Mike's Hospital (Unity Health)

    NOT_YET_RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • St. Paul's Hospital

    NOT_YET_RECRUITING

    Saskatoon, Saskatchewan, S7M 0Z9, Canada

  • Stollery Children's Hospital

    NOT_YET_RECRUITING

    Edmonton, Alberta, T6G 1C9, Canada

  • The Sydney Children's Hospital Network

    NOT_YET_RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Toronto General Hospital Research Institute (UHN)

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2N2, Canada

  • University of Alberta Hospital

    NOT_YET_RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Toronto - Hospital for Sick Kids

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 1E8, Canada

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia