Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.

Launched by MAYO CLINIC · Aug 21, 2024

Keywords

ClinConnect Summary

The RIOT Trial is a research study that aims to find out if it's safe and effective to stop using a medication called Mycophenolate Mofetil (MMF) in older patients who have received a kidney transplant. This study is specifically for individuals who are 55 years or older and have had a kidney transplant, either for the first time or as a second transplant. Researchers want to compare the health outcomes of participants who stop taking MMF with those who continue the standard treatment.

To be eligible for this trial, participants must be 55 years or older, have received a single kidney transplant, and be HIV negative. Certain medical conditions or past treatments may disqualify someone from participating, especially if they might affect their health or the study results. Participants will be monitored closely to ensure their well-being throughout the study. This trial is not yet recruiting, but it represents an important step in understanding how to best manage medications for older kidney transplant recipients.

Gender

ALL

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.