Reduced Immunosuppression for Older Kidney Transplant Recipients

(RIOT Trial)

Overseen By Nong Yowe Braaten

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: MMF

Disqualifiers: Acute rejection, DSA MFI >500, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

350 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial involves withdrawing Mycophenolate Mofetil (MMF) for some participants, but it does not specify if you need to stop other medications. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Mycophenolate Mofetil (MMF) for older kidney transplant recipients?

Research shows that Mycophenolate Mofetil (MMF) significantly reduces the risk of acute rejection in kidney transplant patients and is associated with better long-term outcomes compared to other treatments like azathioprine. In studies, MMF has been shown to improve graft survival and reduce the need for additional medications to prevent rejection. ^{1 2 3 4 5}

Is mycophenolate mofetil (MMF) generally safe for humans?

Mycophenolate mofetil (MMF) is generally considered safe for humans, but it can cause side effects like stomach issues and increase the risk of infections and certain cancers. Careful monitoring is important to manage these risks. ^{3 5 6 7 8}

How does the drug mycophenolate mofetil (MMF) differ from other treatments for older kidney transplant recipients?

Mycophenolate mofetil (MMF) is unique because it is a powerful immunosuppressant that reduces the risk of acute rejection in kidney transplants by about 50% when combined with other drugs like cyclosporine and prednisone. It is considered safer and better tolerated than older drugs like azathioprine, although it can cause gastrointestinal issues and increase the risk of infections. ^{3 5 6 9 10}

What is the purpose of this trial?

The purpose of this research is to determine the safety and efficacy of withdrawing MMF (Mycophenolate Mofetil) in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant. We are comparing them to patients who receive the standard of care Mycophenolate Mofetil.

Research Team

Mark Stegall, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for kidney transplant recipients aged 55 or older. It's not specified who can't join, but typically those with additional serious health issues or incompatible medications would be excluded.

Inclusion Criteria

HIV negative

I have not had any organ transplants, but I may have had a stem cell transplant using my own cells.

I am over 55 and have had one or two kidney transplants.

Exclusion Criteria

This criterion does not apply to me as it lacks specific information.

De novo DSA

4-Month Exclusion Criteria:

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive standard immunosuppression medication including Mycophenolate Mofetil

4 months

Regular visits for monitoring and standard of care kidney biopsy

Randomization and Treatment Adjustment

Participants are randomized into either MMF Maintenance or MMF Withdrawal groups, or continue in the Non-Randomized group

6 months

Regular visits for monitoring and adjustment of medication

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of graft function and rejection

2 years

Visits at 12 and 24 months post-transplant for questionnaires and assessments

Treatment Details

Interventions

• Mycophenolate Mofetil (MMF)

Trial Overview The study is testing the safety and effectiveness of stopping Mycophenolate Mofetil (MMF), a common post-transplant medication, compared to continuing it as standard care in older kidney transplant patients.

Participant Groups

Group I: MMF Withdrawal Group Experimental Treatment 1 Intervention

Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.

Group II: MMF Maintenance Group Active Control 1 Intervention

Individuals randomized to the MMF Maintenance Group will not be withdrawn from their MMF and will continue to follow their standard of care immunosuppression medications.

Group III: Non-Randomized Group Active Control 1 Intervention

Individuals who do not meet eligibility for randomization will continue in the study and continue to follow study related visits. Individuals will continue with their current immunosuppression medication.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Transplant Genomics, Inc.

Industry Sponsor

Trials

16

Recruited

4,800+

Eurofins

Industry Sponsor

Trials

20

Recruited

8,100+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Five-year results of renal transplantation on immunosuppressive triple therapy with mycophenolate mofetil. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Mycophenolate mofetil versus azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression (ATHENA): A pragmatic randomized trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Mycophenolate mofetil in renal transplantation: results from the U.S. randomized trials. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Mycophenolate mofetil vs azathioprine in a large population of elderly renal transplant patients. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Disseminated varicella infection in pediatric renal transplant recipients treated with mycophenolate mofetil. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Mycophenolates: The latest modern and potent immunosuppressive drugs in adult kidney transplantation: What we should know about them? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Mycophenolate mofetil dose reduction in renal transplant recipients: a 5-year follow-up study. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Does mycophenolate mofetil decrease the recurrent acute rejection in renal transplant recipients. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Chronic renal allograft rejection: no response to mycophenolate mofetil. [2019]