Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 350
- 试验地点
- 4
- 主要终点
- Graft Failure
研究概览
简要总结
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.
详细描述
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on current medication, or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Time of Transplant Exclusion Criteria:
- •The results of the most recent DSA testing indicate DSA with an MFI >
- •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
- •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.
研究组 & 干预措施
MMF Maintenance Group
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.
干预措施: Mycophenolate Mofetil (MMF) Maintenance Group (Drug)
MMF Withdrawal Group
Individuals randomized to the MMF Maintenance Group will be withdrawn from their MMF immunosuppression medication from Month 4 to Month 10 post-transplant.
干预措施: Mycophenolate Mofetil (MMF) Withdrawal Group (Drug)
结局指标
主要结局
Graft Failure
时间窗: 4 to 24 months post transplant.
Total number of subjects to experience graft failure from the renal transplant
Patient Deaths
时间窗: 4 to 24 months post transplant.
Total number of subject deaths from 4-24 months post transplant.
Acute Rejection
时间窗: 4 to 24 months post transplant.
Total number of subjects to experience acute rejection of the renal transplant
次要结局
- eGFR (estimated glomerular filtration rate)(2 years post transplant)
- BANFF scores(2 years post transplant.)
- Transplant Related Symptom (CIRS) Questionnaire(2 years post transplant.)
- Serious Adverse Events (SAE)(1 and 2 years post transplant.)
- Single antigen beads (SAB) for donor-specific antibodies(Baseline, 1 year post transplant and 2 years post transplant)
- Albumin/Creatinine Ratio (Microalbumin) Urine(2 years post transplant)
- Absolute lymphocyte counts(1 year post transplant and 2 years post transplant)