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

31. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard of Care
Participants continue tacrolimus-based maintenance immunosuppression (tacrolimus, MMF, with or without prednisone)
Medicin: Tacrolimus (Kidney transplant maintenance immunosuppression)
Administration of Tacrolimus
Medicin: Mycophenoate Mofetil
Participants are administered MMF
Medicin: Prednisone (SOC arm)
Participants in SOC arm may be administered Prednisone as indicated
Eksperimentel: 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.
Medicin: Tacrolimus (Kidney transplant maintenance immunosuppression)
Administration of Tacrolimus
Medicin: Mycophenoate Mofetil
Participants are administered MMF
Medicin: Prednisone (MMF Elimination arm)
Participants in the MMF Elimination arm may be administered prednisone as indicated

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of MMF Elimination
Tidsramme: 6 months
Proportion of eligible participants enrolled and retained through completion of the intervention
6 months
Protocol Adherence
Tidsramme: 6 months
Proportion of participants completing the assigned treatment strategy without major protocol deviations
6 months
Biomarker Monitoring Completion
Tidsramme: 6 months
Proportion of scheduled biomarker assessments successfully completed.
6 months
Clinical Composite Event Rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12
Tidsramme: 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
Tidsramme: 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
Tidsramme: Months 6 and 12
Number of participants experiencing one or more infections
Months 6 and 12
Comparison of Participants Hospitalized
Tidsramme: Months 6 and 12
Number of participants experiencing one or more hospitalizations
Months 6 and 12
Comparison of Total Hospitalizations
Tidsramme: Months 6 and 12
Total number of hospitalizations across all participants
Months 6 and 12
Comparison of adverse events
Tidsramme: Months 6 and 12
Number of participants experiencing one or more adverse events
Months 6 and 12
Comparison of serious adverse events
Tidsramme: Months 6 and 12
Number of participants experiencing one or more serious adverse events
Months 6 and 12
De Novo Donor-Specific Antibody Incidence
Tidsramme: Month 12
Number of participants who develop confirmed de novo donor-specific antibodies after randomization
Month 12
Time to De Novo Donor-Specific Antibody
Tidsramme: Month12
Time from randomization to first confirmed de novo donor-specific antibody
Month12
Donor-Derived Cell-Free DNA (dd-cfDNA)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Month 12
Longitudinal change in urine CXCL10 and its predictive performance for rejection and de novo donor-specific antibody
Month 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Virginia Commonwealth University

Efterforskere

  • Ledende efterforsker: Amber Paulus, PhD, Virginia Commonwealth University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. august 2026

Primær færdiggørelse (Anslået)

1. februar 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

18. august 2026

Først indsendt, der opfyldte QC-kriterier

31. august 2026

Først opslået (Faktiske)

8. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HM300000943

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

10 years after study completion

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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