Steroids for Kidney Transplant Rejection

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen byJulie Ho, FRCPC

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Sydney

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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's 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

The TACKLE-IT Trial is for patients who have had a kidney or kidney-pancreas transplant and are experiencing organ rejection, specifically Acute T cell mediated rejection (TCMR). The trial aims to find the right steroid dose to treat this condition.

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

My ethnicity or gender does not affect my eligibility.

+1 more

Exclusion Criteria

I have ongoing kidney disease, like repeated kidney inflammation or a virus affecting my kidneys.

I do not have any active infections or cancers that would prevent me from receiving treatments to boost my immune system.

Unable to adhere to the study protocol

+8 more

Participant Groups

This study tests different doses of steroids, Methylprednisolone and Prednisone, to determine the most effective amount that can manage acute TCMR in transplant recipients without causing significant side effects.

4Treatment groups

Experimental Treatment

Active Control

Group I: Lower dose IV methylprednisolone x Lower dose oral prednisoneExperimental Treatment2 Interventions

Lower dose IV MP (250 mg daily x 3 days in adults or 150 mg/m² daily x 3, or to a max 250 mg/dose in children (\<18 years), with lower dose (25mg daily x 7 days, or 15mg/m2 for those \< 18 years ) vs higher dose (50mg daily x 7 days, or or 30mg/m2 for those \< 18 years) oral prednisone augmentation.

Group II: Lower dose IV methylprednisolone x Higher dose oral prednisoneExperimental Treatment2 Interventions

Lower dose IV MP (250 mg daily x 3 days in adults or 150 mg/m² daily x 3, or to a max 250 mg/dose in children (\<18 years), with higher dose (50mg daily x 7 days, or or 30mg/m2 for those \< 18 years) oral prednisone augmentation.

Group III: Higher dose IV methylprednisolone x lower dose oral prednisoneActive Control2 Interventions

Higher dose IV MP (500 mg daily x 3 days in adults or 300 mg/m² daily x 3 or to a max 500 mg/dose in children (\<18 years), with lower dose (25mg daily x 7 days, or 15mg/m2 for those \< 18 years) oral prednisone augmentation.

Group IV: Higher dose IV methylprednisolone x higher dose oral prednisoneActive Control2 Interventions

Higher dose IV MP (500 mg daily x 3 days in adults or 300 mg/m² daily x 3 or to a max 500 mg/dose in children (\<18 years), with higher dose (50mg daily x 7 days, or 30mg/m2 for those \< 18 years) oral prednisone augmentation.

Methylprednisolone is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Medrol for: