Extended-Release Tacrolimus for Kidney Transplant Recipients

(Neuro-KTR Trial)

Overseen by Leonardo V. Riella, MD, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Leonardo V. Riella, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for older kidney transplant recipients who can consent, have stable kidney function and tacrolimus levels, speak English or Spanish, and are on immediate-release tacrolimus. It's not for those with severe liver disease, recent rejection episodes, advanced dementia, blindness, Parkinson's disease, very low eGFR rates (<15), intellectual disabilities, pregnancy, dual organ transplants, active cancer or uncontrolled mental health conditions.

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

It has been over a year since my last kidney transplant.

Exclusion Criteria

My liver is not working properly.

Rejection within the last three months

History of moderate to severe dementia (defined by Dementia Severity Rating Scale ≥19)

Treatment Details

Interventions

• Extended-Release Tacrolimus (Immunosuppressant)

Trial Overview The study compares the effects of continuing with immediate-release tacrolimus versus switching to extended-release tacrolimus on neurocognitive functions in these patients. Participants will be randomly assigned to one of the two treatment groups.

Participant Groups

Group I: Envarsus XR conversion Experimental Treatment 1 Intervention

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.

Group II: Prograf maintenance Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Veloxis Pharmaceuticals

Industry Sponsor

Trials

43

Recruited

3,200+