Kidney Transplant RecipientEarly Phase 1OPTIMA-KTNCT07806136
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
A Early Phase 1 study testing Tacrolimus (Kidney transplant maintenance immunosuppression), Mycophenoate Mofetil and Prednisone (SOC arm) in people with Kidney Transplant Recipient, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Kidney Transplant Recipient
- What is being tested?
- Tacrolimus (Kidney transplant maintenance immunosuppression), Mycophenoate Mofetil and Prednisone (SOC arm)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Aug 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
Amber Paulus, 804-827-1743, amber.paulus@vcuhealth.org
Amber Paulus, PhD
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Kidney Transplant Recipient
- Being tested
- Tacrolimus (Kidney transplant maintenance immunosuppression), Mycophenoate Mofetil, Prednisone (SOC arm), Prednisone (MMF Elimination arm)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus (Kidney transplant maintenance immunosuppression)Drug
Administration of Tacrolimus
Mycophenoate MofetilDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants continue tacrolimus-based maintenance immunosuppression (tacrolimus, MMF, with or without prednisone) Receives: Drug: Tacrolimus (Kidney transplant maintenance immunosuppression); Drug: Mycophenoate Mofetil; Drug: Prednisone (SOC arm) |
| MMF Elimination (Mycophenolate Mofetil ) | Experimental | 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. Receives: Drug: Tacrolimus (Kidney transplant maintenance immunosuppression); Drug: Mycophenoate Mofetil; Drug: Prednisone (MMF Elimination arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MMF Elimination
Proportion of eligible participants enrolled and retained through completion of the intervention
Measured: 6 months
Protocol Adherence
Proportion of participants completing the assigned treatment strategy without major protocol deviations
Measured: 6 months
Biomarker Monitoring Completion
Proportion of scheduled biomarker assessments successfully completed.
Measured: 6 months
Clinical Composite Event Rate
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.
Measured: 6 months
Secondary outcomes (12)
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12.
Measured: Months 6 and 12
Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12
Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12.
Measured: Months 6 and 12
Comparison of Infection incidence
Number of participants experiencing one or more infections
Measured: Months 6 and 12
Comparison of Participants Hospitalized
Number of participants experiencing one or more hospitalizations
Measured: Months 6 and 12
Comparison of Total Hospitalizations
Total number of hospitalizations across all participants
Measured: Months 6 and 12
Comparison of adverse events
Number of participants experiencing one or more adverse events
Measured: Months 6 and 12
Comparison of serious adverse events
Number of participants experiencing one or more serious adverse events
Measured: Months 6 and 12
De Novo Donor-Specific Antibody Incidence
Number of participants who develop confirmed de novo donor-specific antibodies after randomization
Measured: Month 12
Time to De Novo Donor-Specific Antibody
Time from randomization to first confirmed de novo donor-specific antibody
Measured: Month12
Donor-Derived Cell-Free DNA (dd-cfDNA)
Longitudinal change in dd-cfDNA and its predictive performance for rejection and de novo donor-specific antibody
Measured: Month 12
Urine CXCL9 Concentration (pg/mL)
Longitudinal change in urine CXCL9 and its predictive performance for rejection and de novo donor-specific antibody
Measured: Month 12
Urine CXCL10 Concentration (pg/mL)
Longitudinal change in urine CXCL10 and its predictive performance for rejection and de novo donor-specific antibody
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amber Paulus, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806136
- Sponsor's protocol ID
- HM300000943
- Acronym
- OPTIMA-KT
- Status last verified
- Nov 2026
- First submitted
- 18 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07806136
- Acronym / sponsor ID
- OPTIMA-KT / HM300000943
- Conditions
- Kidney Transplant Recipient
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Tacrolimus (Kidney transplant maintenance immunosuppression), Drug: Mycophenoate Mofetil, Drug: Prednisone (SOC arm)Participants continue tacrolimus-based maintenance immunosuppression (tacrolimus, MMF, with or without prednisone) |
| MMF Elimination (Mycophenolate Mofetil ) | Experimental | Drug: Tacrolimus (Kidney transplant maintenance immunosuppression), Drug: Mycophenoate Mofetil, Drug: Prednisone (MMF Elimination arm)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus (Kidney transplant maintenance immunosuppression)Administration of Tacrolimus | Drug | MMF Elimination (Mycophenolate Mofetil ), Standard of Care |
| Mycophenoate MofetilParticipants are administered MMF | Drug | MMF Elimination (Mycophenolate Mofetil ), Standard of Care |
| Prednisone (SOC arm)Participants in SOC arm may be administered Prednisone as indicated | Drug | Standard of Care |
| Prednisone (MMF Elimination arm)Participants in the MMF Elimination arm may be administered prednisone as indicated | Drug | MMF Elimination (Mycophenolate Mofetil ) |
Primary outcome
Feasibility of MMF Elimination
Time frame: 6 months
Proportion of eligible participants enrolled and retained through completion of the intervention
Protocol Adherence
Time frame: 6 months
Proportion of participants completing the assigned treatment strategy without major protocol deviations
Biomarker Monitoring Completion
Time frame: 6 months
Proportion of scheduled biomarker assessments successfully completed.
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.
12 secondary outcomes
Compare estimated glomerular filtration rate (eGFR) trajectory 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
Time frame: Months 6 and 12
Comparison of Infection incidence
Time frame: Months 6 and 12
Comparison of Participants Hospitalized
Time frame: Months 6 and 12
Comparison of Total Hospitalizations
Time frame: Months 6 and 12
Comparison of adverse events
Time frame: Months 6 and 12
Comparison of serious adverse events
Time frame: Months 6 and 12
De Novo Donor-Specific Antibody Incidence
Time frame: Month 12
Time to De Novo Donor-Specific Antibody
Time frame: Month12
Donor-Derived Cell-Free DNA (dd-cfDNA)
Time frame: Month 12
Urine CXCL9 Concentration (pg/mL)
Time frame: Month 12
Urine CXCL10 Concentration (pg/mL)
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amber Paulus, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tacrolimus (Kidney transplant maintenance immunosuppression), Mycophenoate Mofetil and Prednisone (SOC arm) in people with Kidney Transplant Recipient, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber Paulus, PhD ((804) 827-1743, amber.paulus@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of MMF Elimination (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.