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NCT Number: NCT07806136

Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients

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.

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Key information

Conditions

Kidney Transplant Recipient

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus (Kidney transplant maintenance immunosuppression)

Drug

Administration of Tacrolimus

Mycophenoate Mofetil

Drug

Participants are administered MMF

Prednisone (SOC arm)

Drug

Participants in SOC arm may be administered Prednisone as indicated

Prednisone (MMF Elimination arm)

Drug

Participants in the MMF Elimination arm may be administered prednisone as indicated

Primary outcomes

  1. Feasibility of MMF Elimination

    Time frame: 6 months

    Proportion of eligible participants enrolled and retained through completion of the intervention

  2. Protocol Adherence

    Time frame: 6 months

    Proportion of participants completing the assigned treatment strategy without major protocol deviations

  3. Biomarker Monitoring Completion

    Time frame: 6 months

    Proportion of scheduled biomarker assessments successfully completed.

  4. Clinical Composite Event Rate

    Time frame: 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.

Secondary outcomes

  1. Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12

    Time frame: Months 6 and 12

    Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12.

  2. Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12

    Time frame: Months 6 and 12

    Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12.

  3. Comparison of Infection incidence

    Time frame: Months 6 and 12

    Number of participants experiencing one or more infections

  4. Comparison of Participants Hospitalized

    Time frame: Months 6 and 12

    Number of participants experiencing one or more hospitalizations

  5. Comparison of Total Hospitalizations

    Time frame: Months 6 and 12

    Total number of hospitalizations across all participants

  6. Comparison of adverse events

    Time frame: Months 6 and 12

    Number of participants experiencing one or more adverse events

  7. Comparison of serious adverse events

    Time frame: Months 6 and 12

    Number of participants experiencing one or more serious adverse events

  8. De Novo Donor-Specific Antibody Incidence

    Time frame: Month 12

    Number of participants who develop confirmed de novo donor-specific antibodies after randomization

  9. Time to De Novo Donor-Specific Antibody

    Time frame: Month12

    Time from randomization to first confirmed de novo donor-specific antibody

  10. Donor-Derived Cell-Free DNA (dd-cfDNA)

    Time frame: Month 12

    Longitudinal change in dd-cfDNA and its predictive performance for rejection and de novo donor-specific antibody

  11. Urine CXCL9 Concentration (pg/mL)

    Time frame: Month 12

    Longitudinal change in urine CXCL9 and its predictive performance for rejection and de novo donor-specific antibody

  12. Urine CXCL10 Concentration (pg/mL)

    Time frame: Month 12

    Longitudinal change in urine CXCL10 and its predictive performance for rejection and de novo donor-specific antibody

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Paulus, PhD

CONTACT

[email protected]

(804) 827-1743

Natalie Kilmarx

CONTACT

[email protected]

(804) 828-7522

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Acronym: OPTIMA-KT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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