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NCT06751992 | NOT YET RECRUITING | Kidney Transplant Recipients

Neurocognitive Function Changes with Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Sponsor:

Massachusetts General Hospital

Information provided by (Responsible Party):

Leonardo V. Riella, MD, PhD

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).

Condition or disease

Kidney Transplant Recipients

Old Age

Intervention/treatment

Conversion to extended-release tacrolimus

Maintenance of immediate-release tacrolimus

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 92 participants
Masking : NONE
Primary Purpose : PREVENTION
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
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2027-05-01
Estimated Study Completion Date : 2027-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Neurocognitive Function Changes with Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

Location Details

NCT06751992

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Massachusetts

MGH Kidney Transplant Clinic

Boston, Massachusetts, United States, 02114