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

NCT06751992 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-03-19

No results posted yet for this study

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

Interventions

DRUG

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

DRUG

Maintenance of immediate-release tacrolimus

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

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Leonardo V. Riella, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2027-05-01
Completion
2027-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06751992 on ClinicalTrials.gov