Envarsus XR for Kidney Transplant Patients
(OPERATOR Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAnthony Langone, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess cognitive outcome and quality of life in stable renal transplant patients treated with twice daily tacrolimus at baseline and after switching to Envarsus XL. The study is designed to see if switching patients from Tacrolimus to Envarsus treatment improves cognitive function.

Eligibility Criteria

This trial is for English-speaking adults aged 18-70 who've had a kidney transplant between 4 weeks and 10 years ago. They must be on a stable dose of Tacrolimus with specific blood levels, not planning to start interfering medications, and have no severe visual/hearing impairments or medical conditions that could affect participation.

Inclusion Criteria

Patients must be able to understand English and provide written informed consent

Males and females between 18 and 70 years of age

Patients receiving a stable dose (i.e., no dose adjustments) of TAC-IR for a minimum of 4-7 days at screening

+5 more

Exclusion Criteria

Patients with an estimated glomerular filtration rate (eGFR) (MDRD4) < 25 mL/min at screening

Patients who have a history of any of the following, based on documentation of clinical conditions and concomitant medications in the medical records: Cognitive decline secondary to stroke, per Investigator discretion

Patients with an episode of biopsy-proven or suspected acute rejection that requires treatment within 3 months of screening

+20 more

Participant Groups

The study tests if switching from twice-daily Tacrolimus (Prograf) to Envarsus XR improves cognitive function in stable renal transplant patients. It assesses the impact of this medication change on their mental capabilities and quality of life.

1Treatment groups

Experimental Treatment

Group I: Change from Prograf to EnvarsusExperimental Treatment1 Intervention

All participants will be switched from Prograf to Envarsus

Envarsus XR is already approved in United States for the following indications:

🇺🇸 Approved in United States as Envarsus XR for: