Recruiting

IR Tacrolimus vs. Envarsus XR

Sponsor:

Massachusetts General Hospital

Code:

NCT06751992

Conditions

Kidney Transplant Recipients

Old Age

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Conversion to extended-release tacrolimus

Maintenance of immediate-release tacrolimus

Study Details

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).

Conditions

Kidney Transplant Recipients

Old Age

Study ID

NCT06751992

Start date

Mar 17, 2026

Status verified date

Mar, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Envarsus XR conversion

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.

active comparator: Prograf maintenance

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.

Interventions

Conversion to extended-release tacrolimus

Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment

Maintenance of immediate-release tacrolimus

Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment

Primary outcome measure

  • The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score) [ Time Frame: 12 month ]
  • The difference in changes of neurocognitive function in intermediate-term (Fluid composite, standard score) [ Time Frame: 12 month ]
  • The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, standard score) [ Time Frame: 12 month ]
  • The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, T score) [ Time Frame: 12 month ]
  • The difference in changes of neurocognitive function in intermediate-term (Fluid composite, T score) [ Time Frame: 12 month ]
  • The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, T score) [ Time Frame: 12 month ]

Central Contacts and Locations

Central contacts

Leonardo V. Riella, MD, PhD

6177240345lriella@mgh.harvard.edu

Amelia Stocking

617-724-1976astocking@mgh.harvard.edu

Locations

MGH Kidney Transplant Clinic

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Riella, M.D., Ph.D.

877-644-2860lriella@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 28, 2026

Last verified

Mar, 2026

Keywords

  • Neurocognitive function
  • Tacrolimus
  • Kidney transplant recipients
  • Tremor
  • Insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-28.