Steroids for Kidney Transplant Rejection
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?
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
Julie Ho, FRCPC
Principal Investigator
University of Manitoba
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive high or low dose IV methylprednisolone and oral prednisone to treat acute T cell mediated rejection
Follow-up
Participants are monitored for safety, effectiveness, and various outcomes such as infections, quality of life, and kidney function
Long-term monitoring
Participants are monitored for long-term outcomes such as chronic fibrosis, cancer, and all-cause death
Treatment Details
Interventions
- Methylprednisolone
- Prednisone
Methylprednisolone is already approved in United States, European Union, Canada for the following indications:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
- 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
University of Manitoba
Collaborator