Finding the right steroid dose for acute T cell rejection after kidney or kidney–pancreas transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TACKLE-IT is a randomized, triple‑blind, 2x2 factorial, non‑inferiority trial embedded in registries that compares high versus low dose IV methylprednisolone and high versus low dose oral prednisone taper as first‑line therapy for acute T cell–mediated rejection (TCMR) after kidney or simultaneous pancreas–kidney transplant. The trial enrolls children (age ≥2 years) and adults with biopsy‑proven TCMR (≥ Banff borderline, minimum i1) and randomizes participants to one of four steroid dosing strategies. It is conducted across multiple transplant centers under international stakeholder and professional society collaboration, with standardized safety monitoring and graft outcome follow‑up. The primary aim is to determine the minimally acceptable steroid dose that preserves graft function while reducing steroid‑related harms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• Queensland Children's Hospital
  South Brisbane, Queensland, Australia Recruiting
• John Hunter Hospital
  Lambton, New South Wales, Australia Not yet recruiting
• Prince of Wales Hospital
  Randwick, New South Wales, Australia Not yet recruiting
• The Sydney Children's Hospital Network
  Westmead, New South Wales, Australia Not yet recruiting
• Princess Alexandra Hospital
  Woolloongabba, Queensland, Australia Not yet recruiting

Study contacts

• Principal investigator: Germaine Wong, PhD, FRACP — University of Sydney
• Study coordinator: NHMRC Clinical Trials Centre THE UNIVERSITY OF SYDNEY
• Email: tackle-it.study@sydney.edu.au
• Phone: +61 2 9562 5000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating cell-free DNA in kidney transplant patients

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• Using gene analysis to improve diagnosis of liver transplant rejection

  This study is testing whether analyzing specific genes in liver transplant patients can help doctors diagnose rejection faster and more accurately.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT06734013

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.