Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients (OPTIMA-KT)
31 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
20
Fase
- Vroege fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Amber Paulus, PhD
- Telefoonnummer: (804) 827-1743
- E-mail: amber.paulus@vcuhealth.org
Studie Contact Back-up
- Naam: Natalie Kilmarx
- Telefoonnummer: (804) 828-7522
- E-mail: natalie.salsini@vcuhealth.org
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Standard of Care
Participants continue tacrolimus-based maintenance immunosuppression (tacrolimus, MMF, with or without prednisone)
|
Administration of Tacrolimus
Participants are administered MMF
Participants in SOC arm may be administered Prednisone as indicated
|
|
Experimenteel: 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.
|
Administration of Tacrolimus
Participants are administered MMF
Participants in the MMF Elimination arm may be administered prednisone as indicated
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility of MMF Elimination
Tijdsspanne: 6 months
|
Proportion of eligible participants enrolled and retained through completion of the intervention
|
6 months
|
|
Protocol Adherence
Tijdsspanne: 6 months
|
Proportion of participants completing the assigned treatment strategy without major protocol deviations
|
6 months
|
|
Biomarker Monitoring Completion
Tijdsspanne: 6 months
|
Proportion of scheduled biomarker assessments successfully completed.
|
6 months
|
|
Clinical Composite Event Rate
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Months 6 and 12
|
Number of participants experiencing one or more infections
|
Months 6 and 12
|
|
Comparison of Participants Hospitalized
Tijdsspanne: Months 6 and 12
|
Number of participants experiencing one or more hospitalizations
|
Months 6 and 12
|
|
Comparison of Total Hospitalizations
Tijdsspanne: Months 6 and 12
|
Total number of hospitalizations across all participants
|
Months 6 and 12
|
|
Comparison of adverse events
Tijdsspanne: Months 6 and 12
|
Number of participants experiencing one or more adverse events
|
Months 6 and 12
|
|
Comparison of serious adverse events
Tijdsspanne: Months 6 and 12
|
Number of participants experiencing one or more serious adverse events
|
Months 6 and 12
|
|
De Novo Donor-Specific Antibody Incidence
Tijdsspanne: Month 12
|
Number of participants who develop confirmed de novo donor-specific antibodies after randomization
|
Month 12
|
|
Time to De Novo Donor-Specific Antibody
Tijdsspanne: Month12
|
Time from randomization to first confirmed de novo donor-specific antibody
|
Month12
|
|
Donor-Derived Cell-Free DNA (dd-cfDNA)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Month 12
|
Longitudinal change in urine CXCL10 and its predictive performance for rejection and de novo donor-specific antibody
|
Month 12
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Amber Paulus, PhD, Virginia Commonwealth University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
31 augustus 2026
Primaire voltooiing (Geschat)
1 februari 2029
Studie voltooiing (Geschat)
1 augustus 2029
Studieregistratiedata
Eerst ingediend
18 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
31 augustus 2026
Eerst geplaatst (Werkelijk)
8 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 september 2026
Laatste update ingediend die voldeed aan QC-criteria
31 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HM300000943
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
10 years after study completion
IPD-toegangscriteria voor delen
Access will require investigator approval, IRB approval when applicable, and a data use agreement
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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