Simplified Immunosuppression for Kidney Transplant
(SIMPLE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, since the study involves specific immunosuppressive drugs, you may need to adjust your current medication regimen. Please consult with the study team for guidance.
What safety data is available for immunosuppressive treatments in kidney transplants?
The safety of mycophenolate mofetil (MMF) compared to azathioprine (Aza) in kidney transplantation has been evaluated in several studies. A systematic review focused on their side effects, and another study investigated the safety of converting from MMF to Aza in stable renal transplant patients. These studies provide evidence-based insights into the safety profiles of these immunosuppressive treatments.12345
Is the drug combination of Azathioprine, Methylprednisolone, prednisone, Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA), Once-daily envarsus XR, and Tacrolimus a promising treatment for kidney transplant?
Yes, the drug combination is promising for kidney transplant. Studies show that using Mycophenolate mofetil (MMF) with Tacrolimus leads to better outcomes, like fewer cases of the body rejecting the new kidney, compared to using Azathioprine. This combination is effective and safe for kidney transplant patients.23456
What data supports the idea that Simplified Immunosuppression for Kidney Transplant is an effective treatment?
The available research shows that mycophenolate mofetil (MMF), a drug used in Simplified Immunosuppression for Kidney Transplant, is associated with a lower rate of acute rejection compared to azathioprine (AZA). Specifically, MMF results in a 50% lower incidence of acute rejection. Additionally, some studies suggest better long-term kidney survival with MMF compared to AZA, although results vary across different studies. This indicates that MMF may be more effective in preventing the body from rejecting the transplanted kidney.23457
Who Is on the Research Team?
Santhi Voora, MD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 who have recently received a kidney transplant. They should have a cold ischemia time of less than 24 hours if there's a significant mismatch in donor and recipient tissue types, or more than 24 hours for fewer mismatches. Their pre-transplant antibody levels must be low (≤20%).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a once-daily regimen of EnvarsusXR and azathioprine or a twice-daily regimen of immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of graft function and side effects
What Are the Treatments Tested in This Trial?
Interventions
- Azathioprine
- Methylprednisolone, prednisone
- Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)
- Once-daily envarsus XR
- Tacrolimus
Azathioprine is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Veloxis Pharmaceuticals
Industry Sponsor