Extended vs Immediate Release Tacrolimus for Kidney Transplant Rejection

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a randomized, open-label, controlled clinical trial designed to compare clinical outcomes after kidney transplantation using extended-release tacrolimus (Envarsus XR) versus immediate tacrolimus among highly-sensitized kidney transplant recipients. Outcomes to be assessed include the incidence of biopsy-proven acute rejection at 12 months, the presence of de novo and pre-existing donor-specific HLA antibodies, estimated glomerular filtration rate, and the level of donor-derived cell-free DNA.

Eligibility Criteria

This trial is for adults over 18 who've had a kidney transplant and were treated with IVIG and rituximab to reduce immune sensitivity. They must have an acceptable crossmatch from a non-identical donor. It's not for those allergic to the drugs being tested, with recent severe infections, conditions affecting drug absorption, or women at risk of pregnancy without contraception.

Inclusion Criteria

I understand the study and can give my consent.

I have received or will receive IVIG and rituximab treatment around my transplant time.

I have received a kidney transplant from a living or deceased donor.

My donor for the transplant is a match according to specific blood tests.

I am 18 years old or older.

Exclusion Criteria

I have received a kidney and another organ transplant at the same time.

I have tested positive for hepatitis B, C, or HIV.

Participant Groups

The study compares two forms of tacrolimus: extended-release (Envarsus XR) versus immediate-release in highly-sensitized kidney transplant recipients. It looks at rejection rates, antibody presence, kidney function via filtration rate, and levels of donor-derived DNA after 12 months.

2Treatment groups

Experimental Treatment

Active Control

Group I: Extended-release tacrolimusExperimental Treatment1 Intervention

Kidney transplant recipients will receive extended-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.

Group II: Immediate-release tacrolimusActive Control1 Intervention

Kidney transplant recipients will receive immediate-release tacrolimus in addition to standard-dose mycophenolate and prednisone for maintenance immunosuppression.