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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients (OPTIMA-KT)

2026年8月31日 更新者：Virginia Commonwealth University

Optimizing Immunosuppression in Low-Risk Older Adult Kidney Transplant Recipients (OPTIMA-KT): A Prospective, Randomized, Open-Label, Blinded-Endpoint Single-Site Pilot/Feasibility Trial of Biomarker-Guided Mycophenolate Mofetil Elimination

Most kidney transplant recipients take a combination of anti-rejection medicines for the rest of their life. One of these is called mycophenolate mofetil (MMF), also known by the brand name CellCept. While MMF helps protect the kidney, taking it for many years can cause infections, low blood counts, stomach problems, and a higher risk of certain cancers, problems that older adults are especially likely to experience.

We are doing this study to learn whether carefully and slowly stopping MMF in older adults who are doing well after their transplant is as safe as continuing MMF, when we use blood and urine tests to closely watch for any early signs of trouble. The information learned could help future kidney transplant patients use less medicine without losing their transplant.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

To evaluate the feasibility, safety, protocol adherence, biomarker monitoring completion, and preliminary clinical event rates associated with stepwise MMF elimination over 6 months compared with standard-of-care immunosuppression in low-risk older adult kidney transplant recipients.

Secondary objectives. To compare between arms: eGFR trajectory and proteinuria at Months 6 and 12; infection incidence (including CMV and BK), hospitalization, and adverse drug events; de novo DSA incidence and time to de novo DSA; and the kinetics and predictive performance of dd-cfDNA and urine CXCL9 and CXCL10 for rejection and de novo DSA.

Exploratory objectives. To assess the association between PIRCHE-II score and individual primary endpoint components; the performance of combined biomarker panels versus single biomarkers; health-related quality of life and patient-reported outcomes through Month 12; and cost and healthcare resource utilization through Month 12 across study arms.

研究类型

介入性

注册 (估计的)

20

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Greater than 60 years of age
  • Greater than 12 months from kidney transplant
  • Stable maintenance tacrolimus- based immunosuppression for at least 3 months without dose changes greater than 25%
  • PIRCHE-II score less than or equal to 65 calculated from available donor and recipient HLA typing
  • Ability to provide written informed consent and comply with study procedures

Exclusion Criteria:

  • Multi-organ transplant or prior graft loss due to rejection
  • Maintenance immunosuppression including belatacept, cyclosporine, azathioprine, sirolimus, or other agents in lieu of tacrolimus or MMF
  • Steroid-free regimen
  • Active malignancy (excluding non-melanoma skin cancer)
  • Uncontrolled infection
  • BK viremia greater than 10,000 copies/mL, or BK nephropathy
  • High immunologic risk (any preformed DSA, positive crossmatch, or biopsy-proven rejection within the prior 6 months)
  • Pregnancy, breastfeeding, self-reported pregnancy, positive pregnancy test during screening if testing is indicated, or inability/unwillingness to comply with required pregnancy prevention measures if of childbearing potential
  • Inability to comply with study procedures including monthly visits and biospecimen collection
  • Concurrent participation in another conflicting interventional trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Standard of Care
Participants continue tacrolimus-based maintenance immunosuppression (tacrolimus, MMF, with or without prednisone)
药品：Tacrolimus (Kidney transplant maintenance immunosuppression)
Administration of Tacrolimus
药品：Mycophenoate Mofetil
Participants are administered MMF
药品：Prednisone (SOC arm)
Participants in SOC arm may be administered Prednisone as indicated
实验性的：MMF Elimination (Mycophenolate Mofetil )
Mycophenolate Mofetil (MMF) is reduced to approximately 50% of baseline daily dose at Month 1, approximately 25% at Month 2, and discontinued at Month 3, remaining discontinued through Month 6 unless biomarker triggers prompt reinstatement. Tacrolimus trough is maintained at 5 to 8 ng/mL with monthly monitoring and coefficient of variation tracking; prednisone is continued at site-standard dose unless contraindicated.
药品：Tacrolimus (Kidney transplant maintenance immunosuppression)
Administration of Tacrolimus
药品：Mycophenoate Mofetil
Participants are administered MMF
药品：Prednisone (MMF Elimination arm)
Participants in the MMF Elimination arm may be administered prednisone as indicated

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility of MMF Elimination
大体时间：6 months
Proportion of eligible participants enrolled and retained through completion of the intervention
6 months
Protocol Adherence
大体时间：6 months
Proportion of participants completing the assigned treatment strategy without major protocol deviations
6 months
Biomarker Monitoring Completion
大体时间：6 months
Proportion of scheduled biomarker assessments successfully completed.
6 months
Clinical Composite Event Rate
大体时间：6 months
Time to first occurrence of all-cause death, graft loss, biopsy-proven rejection, major infection requiring IV therapy or hospitalization, graft-related hospitalization, or confirmed de novo donor-specific antibody.
6 months

次要结果测量

结果测量
措施说明
大体时间
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12
大体时间：Months 6 and 12
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12.
Months 6 and 12
Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12
大体时间：Months 6 and 12
Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12.
Months 6 and 12
Comparison of Infection incidence
大体时间：Months 6 and 12
Number of participants experiencing one or more infections
Months 6 and 12
Comparison of Participants Hospitalized
大体时间：Months 6 and 12
Number of participants experiencing one or more hospitalizations
Months 6 and 12
Comparison of Total Hospitalizations
大体时间：Months 6 and 12
Total number of hospitalizations across all participants
Months 6 and 12
Comparison of adverse events
大体时间：Months 6 and 12
Number of participants experiencing one or more adverse events
Months 6 and 12
Comparison of serious adverse events
大体时间：Months 6 and 12
Number of participants experiencing one or more serious adverse events
Months 6 and 12
De Novo Donor-Specific Antibody Incidence
大体时间：Month 12
Number of participants who develop confirmed de novo donor-specific antibodies after randomization
Month 12
Time to De Novo Donor-Specific Antibody
大体时间：Month12
Time from randomization to first confirmed de novo donor-specific antibody
Month12
Donor-Derived Cell-Free DNA (dd-cfDNA)
大体时间：Month 12
Longitudinal change in dd-cfDNA and its predictive performance for rejection and de novo donor-specific antibody
Month 12
Urine CXCL9 Concentration (pg/mL)
大体时间：Month 12
Longitudinal change in urine CXCL9 and its predictive performance for rejection and de novo donor-specific antibody
Month 12
Urine CXCL10 Concentration (pg/mL)
大体时间：Month 12
Longitudinal change in urine CXCL10 and its predictive performance for rejection and de novo donor-specific antibody
Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Virginia Commonwealth University

调查人员

  • 首席研究员：Amber Paulus, PhD、Virginia Commonwealth University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月31日

初级完成 (估计的)

2029年2月1日

研究完成 (估计的)

2029年8月1日

研究注册日期

首次提交

2026年8月18日

首先提交符合 QC 标准的

2026年8月31日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年8月31日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HM300000943

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Deidentified individual participant data supporting the published results will be available beginning after publication of the primary results and for 10 years after study completion. Access will require investigator approval, IRB approval when applicable, and a data use agreement

IPD 共享时间框架

10 years after study completion

IPD 共享访问标准

Access will require investigator approval, IRB approval when applicable, and a data use agreement

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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