Image

Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

Recruiting
65 years and older
All
Phase 4

Powered by AI

Overview

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

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

Study details
    Kidney Transplant Recipients
    Old Age

NCT06751992

Massachusetts General Hospital

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.