2026-03-18
minor
Study Status, Study Description, Eligibility, Contacts/Locations v7
Eligibility criteria-250 characters
[...] A 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 limi [...] 4-Month Exclusion Criteria:
Acute rejection episode either c [...] mediated rejection, excluding borderline) at their 4-month biopsy (If obtained per standard of care biopsy ).
Subjects experiencing rejection will not be eligible for randomizatio [...] [...]
Study description+2 characters
[...] t immune cells.
At the time of the 4 month standard of care kidneyfollow biopsyup visit, if participants have not experienced any rejection episode [...]
Study sitescontacts updated at 1 of 3 sites
2025-11-10
minor
Study Status, Eligibility v6
Eligibility criteria+726 characters
[...] utologous 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 medicatio [...] Exclusion Criteria:
Time of Transplant Exclusion Criteria:
T [...] will not be eligible for randomization and MMF withdrawal.
Subjects who are unable to undergo their 4-month standard of care kidney biopsy due to medical contraindications.
De nov [...] [...]
2025-10-01
minor
Study Status, Contacts/Locations v5
2025-06-13
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2030-03-31→2030-12-31
Completion date2030-03-31→2031-03-31
Start dateestimated 2025-07-01→confirmed 2025-06-13
Study sites1→2
2025-05-22
minor
Study Identification, Study Status, Study Description, Eligibility v3
Start date2025-06-01→2025-07-01
Eligibility criteria+38 characters
Inclusion Criteria:
Solitary kidney transplant recipient >55 years of age-first or second transplants.
At most 1 prior solitary kidney transplant.
No other solid organ transplant though recipients of autolog [...]
Exclusion Criteria:
Time of Transplant Exclusion Criteria:
The results of the most recent DSA testing indicate DSA with an MFI >5002000.
The results of the most recent cPRA testing indicate cPRA is above >80% (based on MFI .>2000)
Prior treatment with MMF or need for MMF therapy (To treat a disease including their primary disease).
Has a history of an underlying clinically significant acu [...]
Study description+243 characters
[...] s that are being collected for the study are called Trugraf®, Eurofins TRAC®, Trac-ID and Viracor®Immunophenotyping Tracand 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, i [...]
Study title+5 characters
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
Show 2 earlier versions
2025-02-12
minor
Study Status v2
Primary completion date2029-03-31→2030-03-31
Completion date2029-03-31→2030-03-31
Start date2025-01-02→2025-06-01
2024-10-16
minor
Study Status v1
Start date2024-10-01→2025-01-02
2024-08-21
minor
Original filing