Steroids for Kidney Transplant Rejection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal steroid dose for treating rejection in patients who have received a kidney or kidney-pancreas transplant. The body sometimes rejects these new organs, leading to issues that could impair their function. Researchers will test various doses of two steroids, methylprednisolone (also known as Medrol, Depo-Medrol, or Solu-Medrol) and prednisone, to identify the most effective option. Individuals who have undergone a kidney transplant and are experiencing acute T cell mediated rejection (TCMR) may be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both methylprednisolone and prednisone help manage organ rejection after kidney transplants. Studies have found that lower doses of methylprednisolone, such as 250 mg, can be as effective as higher doses, like 1,000 mg, for treating sudden rejection in kidney transplants. This suggests that lower doses might be safer and cause fewer side effects while maintaining effectiveness.
Prednisone is often used regularly to prevent rejection. Research indicates that ongoing use of steroids like prednisone can cause side effects, but they are crucial for preventing organ rejection. The goal is to find the right dose that prevents rejection with the least side effects.
This trial tests different combinations of low and high doses of these steroids to identify the safest and most effective dose. The trial aims to reduce risks like infections and weight gain, which can occur with high doses of steroids. Although methylprednisolone and prednisone are usually well-tolerated, high doses can lead to issues like diabetes or bone problems. This trial is important for finding a safer dose that remains effective.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they explore varying doses of methylprednisolone and prednisone to combat kidney transplant rejection. Unlike standard care that often uses a one-size-fits-all dosage, these treatments are tailored with both lower and higher dose combinations, potentially optimizing effectiveness while minimizing side effects. The ability to customize steroid doses could lead to more personalized care, improving outcomes for transplant patients by better managing immune responses. This approach seeks to fine-tune the balance between efficacy and patient tolerance, which is a significant step forward in transplant medicine.
What evidence suggests that this trial's treatments could be effective for kidney transplant rejection?
This trial will compare different dosing regimens of steroids to manage kidney transplant rejection. Research has shown that steroids like methylprednisolone and prednisone can help manage this condition. One study found that about 15% of kidney transplant patients who stopped taking prednisone early experienced at least one episode of acute rejection. This finding highlights the important role steroids play in preventing the body from rejecting a new kidney. However, the correct dose is crucial, as excessive amounts can cause side effects like heart problems and infections. Finding the right balance in steroid dosing is key to maintaining the new kidney's health without causing other health issues. Participants in this trial will receive varying doses of IV methylprednisolone and oral prednisone to determine the most effective and safe dosing strategy.678910
Who Is on the Research Team?
Julie Ho, FRCPC
Principal Investigator
University of Manitoba
Germaine Wong, PhD, FRACP
Principal Investigator
University of Sydney
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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