Clinical trial NCT06568549: Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Official title: Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Kidney Transplantation
Mycophenolate Mofetil
Keywords: Kidney Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Transplant Genomics, Inc.
name: Eurofins
First posted: 2024-08-23
Enrollment: 350
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 kidney biopsy, 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on current medication, or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication.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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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).
* 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. compromises their well-being) or that could prevent, or limit the protocol specified assessment.

  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 standard of care biopsy Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal.
* De novo DSA
* 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.

Primary outcomes:
measure: Acute Rejection
timeFrame: 4 to 24 months post transplant.
measure: Patient Deaths
timeFrame: 4 to 24 months post transplant.
measure: Graft Failure
timeFrame: 4 to 24 months post transplant.
Secondary outcomes:
measure: Serious Adverse Events (SAE)
timeFrame: 1 and 2 years post transplant.
measure: eGFR (estimated glomerular filtration rate)
timeFrame: 2 years post transplant
measure: Single antigen beads (SAB) for donor-specific antibodies
timeFrame: Baseline, 1 year post transplant and 2 years post transplant
measure: BANFF scores
timeFrame: 2 years post transplant.
measure: Absolute lymphocyte counts
timeFrame: 1 year post transplant and 2 years post transplant
measure: Transplant Related Symptom (CIRS) Questionnaire
timeFrame: 2 years post transplant.
measure: Albumin/Creatinine Ratio (Microalbumin) Urine
timeFrame: 2 years post transplant
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark D Stegall, M.D.
role: PRINCIPAL_INVESTIGATOR
References: