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TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients

NCT06474273 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-05-06

No results posted yet for this study

Summary

After a kidney or a simultaneous kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection. One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working.

Doctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That is why we need to find the right dose of steroids for each person to treat this.

TACKLE-IT is a study that will try to find the right steroid dose for treating rejection.

Conditions

  • Rejection; Transplant, Kidney
  • Rejection; Transplant, Pancreas

Interventions

DRUG

Methylprednisolone

IV Methylprednisolone

DRUG

Prednisone

Oral prednisone augmentation

Sponsors & Collaborators

  • University of Manitoba

    collaborator OTHER

  • University of Sydney

    lead OTHER

Principal Investigators

  • Germaine Wong, PhD, FRACP · University of Sydney

  • Julie Ho, FRCPC · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-13
Primary Completion
2030-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06474273 on ClinicalTrials.gov