Extended-release tacrolimus to improve thinking and memory in older kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fall Prevention Pathways: A digital program to help older adults reduce fall risk

  A digital, remotely monitored 8-week program is being tested to see if it can reduce fall risk in community-dwelling adults aged 65–85 who are at low to moderate risk.

  Recruiting Emory University · Atlanta, Georgia · NCT07824141

• Mental effort with light resistance training for older adults

  This study tests whether adding a mental effort cue to light resistance training helps older adults build more strength and improve neuromuscular function than light training alone.

  Recruiting Kennesaw State University · Kennesaw, Georgia · NCT07687316

• Combined NMES and Low-Intensity Resistance Training in Older Adults

  This study tests whether pairing electrical stimulation with light resistance training helps older adults gain muscle strength and endurance.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07646405

• Inspiring Seniors to Exercise More with Personalized Music

  This study tests whether personalized tempo-matched music playlists help sedentary adults age 65 and older exercise more and feel better about physical activity.

  Recruiting Emory University · Atlanta, Georgia · NCT07629739

• Diode laser–assisted gum treatment for people with kidney transplants

  This project will test whether adding a diode laser to standard deep dental cleaning (scaling and root planing) helps people with periodontitis who have had a kidney transplant.

  Recruiting at 2 sites Military Hospital 103 · Hanoi, Hadong and 1 other locations · NCT07532694

• Home safety modifications to prevent falls in older adults in Guangzhou

  This project will try simple home changes like anti-slip mats, better lighting, and minor hazard fixes to see if they reduce falls among community-dwelling people aged 60–80 in Guangzhou over 12 months.

  Recruiting Guangzhou Center for Disease Control and Prevention · Guangzhou, Guangdong · NCT07458958

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.