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Taking people in United StatesPhase 4

Thinking and memory after switching to extended-release tacrolimus after kidney transplant

Compares thinking on extended-release versus immediate-release tacrolimus in older kidney recipients.

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Status
Recruiting
Phase
Phase 4
People taking part
92 people, planned
Started
17 Mar 2026
Expected to end
1 Oct 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Conversion to extended-release tacrolimus
  • Maintenance of immediate-release tacrolimus
Record updated
28 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for kidney transplant recipients aged 65 or older who take twice-daily tacrolimus (Prograf). It compares memory and thinking between staying on Prograf and switching to once-daily Envarsus XR.

Age
65 Years and older
Sex
All sexes
Disease stage
At least 1 year since the latest kidney transplant. Kidney function must be stable (less than 20% change between the last two eGFR results).
Earlier treatment
Must be taking immediate-release (IR) tacrolimus as long-term therapy, with a stable tacrolimus level for the last 3 months or more.
Biomarker or test result
Tacrolimus blood level of 5-10 ng/ml over the last 3 months or more.

Main reasons for not taking part

  • Transplant of two organs
  • Transplant rejection in the last three months
  • Moderate to severe dementia, Parkinson's disease, blindness, deafness or intellectual disabilities
  • Active cancer, advanced liver disease, or uncontrolled depression or anxiety
  • Pregnancy, eGFR <15 mL/min/1.73 m2, or total bilirubin >3.0 mg/dL

This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: * ≥1 year since the latest kidney transplantation

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Dual organ transplantation
  • History of moderate to severe dementia (defined by Dementia Severity Rating Scale ≥19)
  • History of Parkinson's disease
  • Decompensated liver disease
  • Active cancer
  • eGFR <15 mL/min/1.73 m2 at the time of enrollment
  • Total bilirubin >3.0 mg/dL
  • Rejection within the last three months
  • Uncontrolled depression or anxiety
  • Blindness
  • Deafness
  • Intellectual disabilities
  • Pregnancy

Where in United States

  • MGH Kidney Transplant ClinicBoston, United StatesContact: Riella, M.D., Ph.D.Taking people

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Envarsus XR conversionTreatment being tested

    Patients who are randomized to this group will receive extended-release tacrolimus (Envarsus XR) at 80 percent of their total daily dose of IR tacrolimus (Prograf) before the switch. Tacrolimus trough level will be obtained 3-4 weeks after the conversion to ensure appropriate dosage.

    Treatment: Conversion to extended-release tacrolimus

  • Prograf maintenanceExisting treatment, for comparison

    Patients in the IR tacrolimus (Prograf) maintenance group will continue with their current dose of IR tacrolimus (Prograf) before enrollment unless the drug trough levels deviate from the therapeutic range.

    Treatment: Maintenance of immediate-release tacrolimus

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Thinking and memory after switching to extended-release tacrolimus after kidney transplantGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
28 May 2026