Kidney TransplantationPhase 4RIOTNCT06568549
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
A Phase 4 study testing Mycophenolate Mofetil (MMF) Maintenance Group and Mycophenolate Mofetil (MMF) Withdrawal Group in people with Kidney Transplantation and Mycophenolate Mofetil, run by Mayo Clinic at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation, Mycophenolate Mofetil
- What is being tested?
- Mycophenolate Mofetil (MMF) Maintenance Group and Mycophenolate Mofetil (MMF) Withdrawal Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2025to 31 Mar 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Solitary kidney transplant recipient >55 years of age. At most 1 prior solitary kidney transplant.
- No other solid organ transplant though recipients of autologous stem cell transplants are eligible.
- HIV negative.
- Subjects must be on tacrolimus and mycophenolate mofetil or Myfortic at the time of consent. Prednisone at the time of consent is optional and is per local standard of care. Patients randomized to MMF withdrawal will be placed on prednisone 5mg/d at 4 months. Use of other immunosuppression medications for maintenance (cyclosporine, azathioprine, belatacept, sirolimus) is excluded.
Who cannot join
- Time of Transplant Exclusion Criteria:
- The results of the most recent DSA testing indicate DSA with an MFI >2000.
- The results of the most recent cPRA testing indicate cPRA is above >80% (based on MFI >2000).
- 4-Month Exclusion Criteria:
- Acute rejection episode either clinical or on biopsy (greater than borderline). Subjects must not experience any type of rejection episodes from the time of transplant and must not show any signs of rejection (Cellular or Antibody mediated rejection, excluding borderline) at their 4-month biopsy (If obtained per standard of care). Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal.
- De novo DSA
Show all 9Show fewer
- Subjects who are not on tacrolimus at the time of randomization will be placed in the non-randomized group.
- Subjects who at the time of or prior to randomization were maintained on mycophenolate mofetil or Myfortic and have had their medication held or temporarily discontinued due to clinical indications (toxicity to the medication, polyoma virus infections, cancer, etc.) remain eligible for randomization.
- Has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings which, in the opinion of the investigator, would make study participation not in the participants best interest (e.g., compromise the well-being) or that could prevent, or limit the protocol-specified assessment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
David A. Legaspi, 904-953-4990, legaspi.david@mayo.edu
Jessica Toukmehji, 904-953-8722, toukmehji.jessica@mayo.edu
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Xavier Lopez, 480-574-4258, lopez.xavier@mayo.edu
Fady Khorany, 480-574-1323, khorany.fady@mayo.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Nong Yowe Braaten, L.P.N., 507-266-6893, braaten.nong@mayo.edu
Esma Kesik, M.D, 507-284-4562, kesik.esma@mayo.edu
About this study
Official title: Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter 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.
Read the detailed description
Participation will be two years and it involves blood collection, collection of medical information and images from standard of care kidney biopsies. Subjects will be asked to complete questionnaires for the study at 12 and 24 months after kidney transplant. The research blood tests that are being collected for the study are called Trugraf®, Eurofins TRAC®, Trac-ID and Immunophenotyping and Single Cell RNA -sequencing. The principal investigator is using this test to see if they can predict and monitor rejection and viral infections in our kidney transplant patients. Immunophenotyping and single cell RNA sequencing tests are being done to identify unique gene expression profiles and their functions in different immune cells.
At the time of the 4 month standard of care follow up visit, if participants have not experienced any rejection episodes or formed any donor specific antibodies (dnDSA) and are still eligible, randomization will occur. Participants will be put into 1 of 2 groups: Mycophenolate Mofetil Maintenance group where the subject would continue on current medication, or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication. If the subject is not eligible to be randomized, they will remain in the study and placed into the Non-Randomized group and continue to have study related visits and procedures like the MMF Maintenance group.
- Conditions
- Kidney Transplantation, Mycophenolate Mofetil
- Being tested
- Mycophenolate Mofetil (MMF) Maintenance Group, Mycophenolate Mofetil (MMF) Withdrawal Group
- Keywords
- Kidney Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate Mofetil (MMF) Maintenance GroupDrug
Also called CellCept
Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Maintenance in Immunosuppression medication.
Mycophenolate Mofetil (MMF) Withdrawal GroupDrug
Also called CellCept
Mycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication.
| Study group | Role | What they receive |
|---|---|---|
| Non-Randomized Group | No 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. |
| MMF Maintenance Group | Active comparator | 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. Receives: Drug: Mycophenolate Mofetil (MMF) Maintenance Group |
| MMF Withdrawal Group | Experimental | Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant. Receives: Drug: Mycophenolate Mofetil (MMF) Withdrawal Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Rejection
Total number of subjects to experience acute rejection of the renal transplant
Measured: 4 to 24 months post transplant.
Patient Deaths
Total number of subject deaths from 4-24 months post transplant.
Measured: 4 to 24 months post transplant.
Graft Failure
Total number of subjects to experience graft failure from the renal transplant
Measured: 4 to 24 months post transplant.
Secondary outcomes (7)
Serious Adverse Events (SAE)
The total number of subjects to experience SAE's. Defined as subjects experience any one of the following: acute cellular or antibody medicated rejection, borderline rejection or dnDSA (De novo donor-specific antibodies)
Measured: 1 and 2 years post transplant.
eGFR (estimated glomerular filtration rate)
eGFR is calculated from a lab blood test using a formula that measures the level of creatinine. In this test a higher number is better. An eGFR value lower than 60 is a sign that the kidneys may not be working properly. Measured as mL/min/1
Measured: 2 years post transplant
Single antigen beads (SAB) for donor-specific antibodies
Single antigen bead (SAB) assay is a lab blood test used to detect human leukocyte antigen antibodies (HLA) and assessing the immunological risk for organ transplant. For HLA-DRβ1/3/4/5 the single molecule mismatches can range from 0-22 and for HLA-DQα1/β1 the single molecule mismatches range from 0-31. Measured as pg/mL.
Measured: Baseline, 1 year post transplant and 2 years post transplant
BANFF scores
The Banff 2018 classification involves scoring numerous characteristics of renal biopsy specimens. The scores can take values of 0, 1, 2, or 3 for each characteristic, indicating increasing severity of disease as the scores increase.
Measured: 2 years post transplant.
Absolute lymphocyte counts
An absolute lymphocytes count is determined by multiplying the total number of white blood cells by the percentage of white blood cells that are lymphocytes. The normal range for lymphocytes is between 800 and 5000 (0.8-5.0) lymphocytes per mL of blood. A normal lymphocytes percentage is 18-45% of total white blood cells. Measured as cells per microliter (cells/µL)
Measured: 1 year post transplant and 2 years post transplant
Transplant Related Symptom (CIRS) Questionnaire
The CIRS questionnaire is a 36-item questionnaire that contains statements that rate transplant symptoms on a scale of 1(None) to 5 (Very Severe). Total scores range from 36-180, lower scores indicate less severe symptoms, higher scores indicate more severe symptoms.
Measured: 2 years post transplant.
Albumin/Creatinine Ratio (Microalbumin) Urine
The urine albumin-creatinine ratio (uACR) test measures the amount of two different substances in urine - albumin (a protein) and creatinine. A value of 30 or higher suggests a higher risk for kidney failure. Measured as mg/g
Measured: 2 years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start13 Jun 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Transplant Genomics, Inc., Eurofins
- Responsible party
- Principal investigator, Mark Stegall, Mayo Clinic
- Investigators
- Mark D Stegall, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568549
- Sponsor's protocol ID
- 24-002574
- Acronym
- RIOT
- Status last verified
- Mar 2026
- First submitted
- 21 Aug 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plans for data sharing may include data summaries consisting of tables, charts, and figures. Data included will be anonymous and could include demographics, clinical data collected during the study and correlations with Trugraf and Viracor results. Aggregate data for demographics, Subject ID, etc. will only be shared for involving of milestones. The clinical study final report and paper submitted for any publication will also be submitted.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
- ClinicalTrials.gov ID
- NCT06568549
- Acronym / sponsor ID
- RIOT / 24-002574
- Conditions
- Kidney Transplantation, Mycophenolate Mofetil
- Keywords
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Transplant Genomics, Inc., Eurofins
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participation will be two years and it involves blood collection, collection of medical information and images from standard of care kidney biopsies. Subjects will be asked to complete questionnaires for the study at 12 and 24 months after kidney transplant. The research blood tests that are being collected for the study are called Trugraf®, Eurofins TRAC®, Trac-ID and Immunophenotyping and Single Cell RNA -sequencing. The principal investigator is using this test to see if they can predict and monitor rejection and viral infections in our kidney transplant patients. Immunophenotyping and single cell RNA sequencing tests are being done to identify unique gene expression profiles and their functions in different immune cells.
At the time of the 4 month standard of care follow up visit, if participants have not experienced any rejection episodes or formed any donor specific antibodies (dnDSA) and are still eligible, randomization will occur. Participants will be put into 1 of 2 groups: Mycophenolate Mofetil Maintenance group where the subject would continue on current medication, or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication. If the subject is not eligible to be randomized, they will remain in the study and placed into the Non-Randomized group and continue to have study related visits and procedures like the MMF Maintenance group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Randomized Group | No 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. |
| MMF Maintenance Group | Active comparator | Drug: Mycophenolate Mofetil (MMF) Maintenance GroupIndividuals randomized to the MMF Maintenance Group will not be withdrawn from their MMF and will continue to follow their standard of care immunosuppression medications. |
| MMF Withdrawal Group | Experimental | Drug: Mycophenolate Mofetil (MMF) Withdrawal GroupIndividuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Solitary kidney transplant recipient >55 years of age. At most 1 prior solitary kidney transplant.
- No other solid organ transplant though recipients of autologous stem cell transplants are eligible.
- HIV negative.
- Subjects must be on tacrolimus and mycophenolate mofetil or Myfortic at the time of consent. Prednisone at the time of consent is optional and is per local standard of care. Patients randomized to MMF withdrawal will be placed on prednisone 5mg/d at 4 months. Use of other immunosuppression medications for maintenance (cyclosporine, azathioprine, belatacept, sirolimus) is excluded.
Key exclusion criteria (9 listed)
- The results of the most recent DSA testing indicate DSA with an MFI >2000.
- The results of the most recent cPRA testing indicate cPRA is above >80% (based on MFI >2000).
- Acute rejection episode either clinical or on biopsy (greater than borderline). Subjects must not experience any type of rejection episodes from the time of transplant and must not show any signs of rejection (Cellular or Antibody mediated rejection, excluding borderline) at their 4-month biopsy (If obtained per standard of care). Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal.
- De novo DSA
- Subjects who are not on tacrolimus at the time of randomization will be placed in the non-randomized group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate Mofetil (MMF) Maintenance GroupAlso: CellCeptMycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Maintenance in Immunosuppression medication. | Drug | MMF Maintenance Group |
| Mycophenolate Mofetil (MMF) Withdrawal GroupAlso: CellCeptMycophenolate Mofetil (MMF), administered orally as standard of care post kidney transplant as part of their immunosuppression regimen. Withdrawal of MMF immunosuppression medication. | Drug | MMF Withdrawal Group |
Primary outcome
Acute Rejection
Time frame: 4 to 24 months post transplant.
Total number of subjects to experience acute rejection of the renal transplant
Patient Deaths
Time frame: 4 to 24 months post transplant.
Total number of subject deaths from 4-24 months post transplant.
Graft Failure
Time frame: 4 to 24 months post transplant.
Total number of subjects to experience graft failure from the renal transplant
7 secondary outcomes
Serious Adverse Events (SAE)
Time frame: 1 and 2 years post transplant.
eGFR (estimated glomerular filtration rate)
Time frame: 2 years post transplant
Single antigen beads (SAB) for donor-specific antibodies
Time frame: Baseline, 1 year post transplant and 2 years post transplant
BANFF scores
Time frame: 2 years post transplant.
Absolute lymphocyte counts
Time frame: 1 year post transplant and 2 years post transplant
Transplant Related Symptom (CIRS) Questionnaire
Time frame: 2 years post transplant.
Albumin/Creatinine Ratio (Microalbumin) Urine
Time frame: 2 years post transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. Plans for data sharing may include data summaries consisting of tables, charts, and figures. Data included will be anonymous and could include demographics, clinical data collected during the study and correlations with Trugraf and Viracor results. Aggregate data for demographics, Subject ID, etc. will only be shared for involving of milestones. The clinical study final report and paper submitted for any publication will also be submitted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark D Stegall, M.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolate Mofetil (MMF) Maintenance Group and Mycophenolate Mofetil (MMF) Withdrawal Group in people with Kidney Transplantation and Mycophenolate Mofetil, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nong Yowe Braaten, LPN (507-266-6893, braaten.nong@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Rejection (time frame: 4 to 24 months post transplant.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.