NCT06751992 Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
| NCT ID | NCT06751992 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Kidney Transplant Recipients |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-03-17 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 92 participants in total. It began in 2026-03-17 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this randomized controlled study is to assess the neurocognitive outcomes between individuals using immediate-release (IR) tacrolimus (Prograf®) and those who were converted to extended-release tacrolimus (Envarsus XR) among older kidney transplant recipients (KTRs).
Eligibility 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
Contact & Investigator
Leonardo V. Riella, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06751992 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Kidney Transplant Recipients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06751992 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06751992 currently recruiting?
Yes, NCT06751992 is actively recruiting participants. Contact the research team at lriella@mgh.harvard.edu for enrollment information.
Where is the NCT06751992 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06751992 clinical trial?
NCT06751992 is sponsored by Massachusetts General Hospital. The principal investigator is Leonardo V. Riella, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 92 participants.
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