TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorUniversity of Sydney
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Mixed rejection.
Active or chronic active ABMR.
Chronic active TCMR. *Patients with concomitant acute TCMR and chronic active TCMR will not be excluded from the trial.
Isolated v1 without inflammation.
Trial design
Treatments tested in this trial
- Methylprednisolone
- Prednisone
Treatment groups
540 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Sydney
Lead sponsor
University of Manitoba
Collaborator
Source ClinicalTrials.gov