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Once-Daily pill may sharpen thinking in older kidney transplant patients

NCT ID NCT06751992

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two anti-rejection drugs in older kidney transplant recipients: a once-daily extended-release version (Envarsus XR) versus the standard twice-daily immediate-release version (Prograf). Researchers will measure changes in thinking, memory, and other cognitive skills over time using standard tests. The goal is to see if the once-daily drug helps preserve or improve brain function better than the twice-daily drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
extended-release tacrolimus (Envarsus XR)
What this could lead to
If it works, this could show that a once-daily anti-rejection drug helps older kidney transplant patients maintain or improve their thinking and memory compared to the standard twice-daily drug.
What could go wrong
This is a small, early-phase study (92 people) looking at cognitive test scores, not major health outcomes. The results may not apply to all kidney transplant patients, and the drug switch might not show a clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

insomnia Tremor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplant recipients Old age

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MGH Kidney Transplant Clinic

    RECRUITING

    Boston, Massachusetts, 02114, United States

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