Overview

Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in HLA Sensitized Kidney Transplant Recipients

Status:
Recruiting

Trial end date:
2022-06-30

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 4

Details

Lead Sponsor:

Cedars-Sinai Medical Center

Collaborator:

Veloxis Pharmaceuticals

Treatments:

Antibodies
Immunoglobulins
Tacrolimus