Actively Recruiting
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Led by Massachusetts General Hospital · Updated on 2026-03-19
92
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
V
Veloxis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MGH Kidney Transplant Clinic
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Leonardo V. Riella, MD, PhD
CONTACT
A
Amelia Stocking
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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