Overview

Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in HLA Sensitized Kidney Transplant Recipients

Status:
Active, not recruiting

Trial end date:
2021-05-09

Target enrollment:

Participant gender:

Summary

The purpose of this study is to demonstrate the safety of tacrolimus extended-release in HLA sensitized (HS, defined as panel reactive antibody ≥ 30%), kidney transplant recipients after desensitization with intravenous immunoglobulin (IVIG) and rituximab +/- plasma exchange (PLEX) per the standard of care with alemtuzumab induction.

Phase:

Phase 4

Details

Lead Sponsor:

Cedars-Sinai Medical Center

Collaborator:

Astellas Pharma Inc

Treatments:

Mycophenolate mofetil
Tacrolimus