540 Participants Needed

Steroids for Kidney Transplant Rejection

Recruiting at 25 trial locations
CG
AR
Overseen ByAngela Rejuso, BMSc(Hons)
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Sydney
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain immunomodulatory agents (drugs that affect the immune system) or are enrolled in other drug trials.

What data supports the effectiveness of the drug Methylprednisolone for kidney transplant rejection?

Research shows that higher doses of Methylprednisolone can reduce the number and severity of rejection episodes early after kidney transplantation. However, it does not significantly improve overall graft survival compared to other steroids like Prednisone.12345

Is the use of steroids like methylprednisolone and prednisone safe for kidney transplant patients?

Steroids like methylprednisolone and prednisone are generally used in kidney transplants, but they can increase the risk of infections like bacterial sepsis (a severe infection) and may cause weight gain. Some studies suggest that high doses of methylprednisolone might slightly increase the risk of complications and mortality.12367

How does the drug Methylprednisolone, Prednisone differ from other treatments for kidney transplant rejection?

Methylprednisolone and Prednisone are steroids used to prevent and treat kidney transplant rejection by suppressing the immune system. They are unique because they can be administered in varying doses to modify the severity of rejection episodes, and they are often used in combination with other immunosuppressive drugs. Unlike some treatments, they are effective in reversing rejection but are not always necessary at the moment of transplantation if other immunosuppressive agents like cyclosporine are used.12378

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 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.

Research Team

JH

Julie Ho, FRCPC

Principal Investigator

University of Manitoba

GW

Germaine Wong, PhD, FRACP

Principal Investigator

University of Sydney

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.
See 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
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high or low dose IV methylprednisolone and oral prednisone to treat acute T cell mediated rejection

3 days for IV treatment, followed by 7 days of oral prednisone
Daily visits for IV treatment, followed by weekly monitoring

Follow-up

Participants are monitored for safety, effectiveness, and various outcomes such as infections, quality of life, and kidney function

48 weeks
Visits at 12, 24, and 48 weeks post-randomization

Long-term monitoring

Participants are monitored for long-term outcomes such as chronic fibrosis, cancer, and all-cause death

48 weeks

Treatment Details

Interventions

  • Methylprednisolone
  • Prednisone
Trial Overview 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.
Participant Groups
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 ) oral prednisone augmentation then return to standard prednisone.
Group II: Lower dose IV methylprednisolone x Higher dose oral prednisoneExperimental Treatment2 Interventions
Lower dose IV MP (250 mg daily x 3 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 , or 30mg/m² daily x 7 for those \< 18 years) oral prednisone augmentation then return to standard prednisone.
Group III: Higher dose IV methylprednisolone x lower dose oral prednisoneActive Control2 Interventions
Higher dose IV MP (500mg daily x 3 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 then return to standard prednisone.
Group IV: Higher dose IV methylprednisolone x higher dose oral prednisoneActive Control2 Interventions
Higher dose IV MP (500 mg daily x 3 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, then return to standard prednisone.

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

🇺🇸
Approved in United States as Medrol for:
  • Allergic reactions
  • Blood disorders
  • Cancer
  • Eye diseases
  • Immune system disorders
  • Inflammatory diseases
  • Respiratory diseases
  • Skin diseases
🇪🇺
Approved in European Union as Depo-Medrol for:
  • Allergic reactions
  • Blood disorders
  • Cancer
  • Eye diseases
  • Immune system disorders
  • Inflammatory diseases
  • Respiratory diseases
  • Skin diseases
🇨🇦
Approved in Canada as Solu-Medrol for:
  • Allergic reactions
  • Blood disorders
  • Cancer
  • Eye diseases
  • Immune system disorders
  • Inflammatory diseases
  • Respiratory diseases
  • Skin diseases

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Sydney

Lead Sponsor

Trials
208
Recruited
417,000+

University of Manitoba

Collaborator

Trials
628
Recruited
209,000+

References

A prospective study of methylprednisolone and prednisone as immunosuppressive agents in clinical renal transplantation. [2013]
Comparison of two different immunosuppressive dosages of methylprednisolone in clinical renal transplantation. [2013]
Steroid avoidance regimens: a comparison of outcomes with maintenance steroids versus continued steroid avoidance in recipients having an acute rejection episode. [2023]
[The use of methylprednisolone in the therapy of renal transplants from cadavers]. [2013]
Oral versus intravenous high-dose steroid treatment of renal allograft rejection. The big shot or not? [2019]
High dose (bolus) intravenous methylprednisolone at the time of kidney homotransplantation. [2019]
Steroid sensitivity of chronic uraemic and renal transplant patients measured by the antibody dependent cellular cytotoxicity reaction. [2013]
Effects of steroids in combination with other pharmacologic immunosuppressive agents. [2013]
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