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Corticosteroid

Steroids for Kidney Transplant Rejection

Phase 4

Waitlist Available

Led By Julie Ho, FRCPC

Research Sponsored by University of Sydney

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Active malignancies or active infection that preclude immunosuppression augmentation

Chronic active TCMR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12, 24 and 48 weeks post-randomization

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to find the correct steroid dose to treat rejection after a kidney or kidney-pancreas transplant. Rejection occurs when the body mistakenly attacks the new organ. One type of rejection,

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Steroids like Methylprednisolone and Prednisone may lead to heart issues, bone problems, severe infections, weight gain among other potential side effects. The trial seeks to minimize these risks by optimizing dosage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a kidney or SPK transplant and a biopsy showing acute rejection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have ongoing chronic active transplant rejection.

Select...

I have active antibody-mediated rejection.

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My condition involves only one area without swelling.

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My rejection episode is classified as severe, at least Banff 2A.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12, 24 and 48 weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12, 24 and 48 weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12, 24 and 48 weeks post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Avoidance of rescue therapies within 12 weeks post-randomisation to achieve histological resolution and/or improvement in allograft function

Histological resolution of biopsy-proven acute rejection

Improvement in allograft function

Secondary study objectives

All cause death and death-censored graft loss

Cancer

Development of acute antibody mediated rejection (ABMR) and mixed rejection (concomitant ABMR + TCMR)

+7 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylprednisolone

2015

Completed Phase 4

~2280

Prednisone

2014

Completed Phase 4

~2500