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Anti-metabolites

Reduced Immunosuppression for Older Kidney Transplant Recipients (RIOT Trial)

Phase 4
Waitlist Available
Led By Mark D Stegall, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Solitary kidney transplant recipient over 55 years of age with first or second transplants
Be older than 18 years old
Must not have
cPRA greater than 80% based on MFI greater than 2000
Acute rejection episode either clinical or on biopsy (excluding borderline) since transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years post transplant.
Awards & highlights

Summary

This trial aims to see if it is safe and effective to stop using Mycophenolate Mofetil (MMF) in kidney transplant recipients who are 55 years or older. Researchers

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, MMF commonly includes risks like upset stomach, increased blood pressure, possible infections due to lowered immunity, and rarely, lymphoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 55 and have had one or two kidney transplants.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My immune system is highly likely to reject a transplanted organ.
Select...
I have had a rejection episode after my transplant.
Select...
I have been treated with MMF or need MMF for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years post transplant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years post transplant. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute Rejection
Graft Failure
Patient Deaths
Secondary study objectives
Absolute lymphocyte counts
Albumin/Creatinine Ratio (Microalbumin) Urine
BANFF scores
+4 more

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01801280
21%
Common cold
5%
Noro virus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mycophenolate Mofetil (MMF)
MMF + PAN
EC-MPS
EC-MPS + PAN

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MMF Withdrawal GroupExperimental Treatment1 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 GroupActive Control1 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 GroupActive Control1 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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,095 Total Patients Enrolled
Transplant Genomics, Inc.Industry Sponsor
15 Previous Clinical Trials
4,471 Total Patients Enrolled
EurofinsIndustry Sponsor
18 Previous Clinical Trials
7,703 Total Patients Enrolled
~233 spots leftby Mar 2029
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