An Early Phase 1 interventional study of Tacrolimus (Kidney transplant maintenance immunosuppression) and Mycophenoate Mofetil in Kidney Transplant Recipient, sponsored by Virginia Commonwealth University. Not yet recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Virginia Commonwealth University · Early Phase 1, Interventional, and Treatment
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.
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.
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants continue tacrolimus-based maintenance immunosuppression (tacrolimus, MMF, with or without prednisone)
Drug: Tacrolimus (Kidney transplant maintenance immunosuppression) · Drug: Mycophenoate Mofetil · Drug: Prednisone (SOC 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.
Drug: Tacrolimus (Kidney transplant maintenance immunosuppression) · Drug: Mycophenoate Mofetil · Drug: Prednisone (MMF Elimination arm)
Administration of Tacrolimus
Participants are administered MMF
Participants in SOC arm may be administered Prednisone as indicated
Participants in the MMF Elimination arm may be administered prednisone as indicated
Feasibility of MMF Elimination
Proportion of eligible participants enrolled and retained through completion of the intervention
Time frame: 6 months
Protocol Adherence
Proportion of participants completing the assigned treatment strategy without major protocol deviations
Time frame: 6 months
Biomarker Monitoring Completion
Proportion of scheduled biomarker assessments successfully completed.
Time frame: 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.
Time frame: 6 months
Compare estimated glomerular filtration rate (eGFR) trajectory at Months 6 and 12
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
Compare Urine Protein-to-Creatinine Ratio (UPCR) Between Arms at Months 6 and 12.
Time frame: Months 6 and 12
Comparison of Infection incidence
Number of participants experiencing one or more infections
Time frame: Months 6 and 12
Comparison of Participants Hospitalized
Number of participants experiencing one or more hospitalizations
Time frame: Months 6 and 12
Comparison of Total Hospitalizations
Total number of hospitalizations across all participants
Time frame: Months 6 and 12
Comparison of adverse events
Number of participants experiencing one or more adverse events
Time frame: Months 6 and 12
Comparison of serious adverse events
Number of participants experiencing one or more serious adverse events
Time frame: Months 6 and 12
De Novo Donor-Specific Antibody Incidence
Number of participants who develop confirmed de novo donor-specific antibodies after randomization
Time frame: Month 12
Time to De Novo Donor-Specific Antibody
Time from randomization to first confirmed de novo donor-specific antibody
Time frame: 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
Time frame: Month 12
Urine CXCL9 Concentration (pg/mL)
Longitudinal change in urine CXCL9 and its predictive performance for rejection and de novo donor-specific antibody
Time frame: Month 12
Urine CXCL10 Concentration (pg/mL)
Longitudinal change in urine CXCL10 and its predictive performance for rejection and de novo donor-specific antibody
Time frame: Month 12
Plan to share: 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
Supporting information: Study protocol, Informed consent form
Time frame: 10 years after study completion
Access criteria: Access will require investigator approval, IRB approval when applicable, and a data use agreement
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Prednisone
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