Extended-release tacrolimus to improve thinking and memory in older kidney transplant recipients
Neurocognitive Function Changes With Once-Daily Extended-Release Tacrolimus (Envarsus XR) Conversion Compared to Twice-Daily Immediate Release Tacrolimus Maintenance Among Older Kidney Transplant Recipients
This will try switching older kidney transplant recipients from immediate-release tacrolimus to an extended-release formulation to see if it improves thinking, memory, or other cognitive symptoms.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06751992 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled, single-center trial at Massachusetts General Hospital compares continuing immediate-release tacrolimus with conversion to an extended-release formulation (Envarsus XR) in older kidney transplant recipients who are at least one year post-transplant and have stable tacrolimus levels. Participants are randomized to either maintain their current immediate-release regimen or be converted to the extended-release product, with neurocognitive testing performed at baseline and follow-up to measure changes in cognition and related symptoms. The trial enrolls patients who receive routine follow-up at the MGH transplant clinic and who speak English or Spanish. Safety monitoring includes routine graft function and tacrolimus trough level checks during the maintenance period.
Who should consider this trial
Good fit: Ideal candidates are older kidney transplant recipients at least one year after transplant who are on stable immediate-release tacrolimus with therapeutic troughs, have stable kidney function, receive care at MGH, and speak English or Spanish.
Not a fit: Patients with moderate-to-severe dementia, Parkinson's disease, recent rejection, dual organ transplants, severe kidney or liver dysfunction, active cancer, uncontrolled psychiatric illness, pregnancy, or other listed exclusions are unlikely to benefit or are not eligible.
Why it matters
Potential benefit: If successful, switching to extended-release tacrolimus could reduce neurotoxic side effects and lead to better cognitive function and quality of life for older transplant recipients.
How similar studies have performed: Some prior work indicates extended-release tacrolimus can lower peak-related side effects such as tremor, but direct evidence showing cognitive improvement in older kidney transplant recipients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to give informed consent for participation in the study * Patients who have regular outpatient follow-up at the Massachusetts General Hospital (MGH) transplant center * ≥1 year since the latest kidney transplantation * On IR tacrolimus as maintenance therapy * At a stable therapeutic tacrolimus level (5-10 ng/ml) over the last ≥3 months * Stable kidney function \[\<20% variability between the last two estimated glomerular filtration rate (eGFR)\] * Utilizing English or Spanish as the primary language Exclusion Criteria: * Dual organ transplantation * Rejection within the last three months * History of moderate to severe dementia (defined by Dementia Severity Rating Scale ≥19) * History of Parkinson's disease * Decompensated liver disease * Active cancer * Uncontrolled depression or anxiety * Blindness * Deafness * Intellectual disabilities * Pregnancy * eGFR \<15 mL/min/1.73 m2 at the time of enrollment * Total bilirubin \>3.0 mg/dL
Where this trial is running
Boston, Massachusetts
- MGH Kidney Transplant Clinic — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Leonardo V. Riella, MD, PhD — Massachusetts General Hospital
- Study coordinator: Leonardo V. Riella, MD, PhD
- Email: lriella@mgh.harvard.edu
- Phone: 6177240345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.