drugset / Trial / NCT03380936

Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients

NCT03380936

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a pilot study to determine if extended release Envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) AMR (antibody mediated rejection) in kidney transplant patients. Subjects will be randomized to either conversion to Envarsus XR (extended release); or, to a standard of care regimen of plasma exchange/IVIG (intravenous immunoglobulin)/rituximab treatments.

Timeline

Start
2018-01-17
Primary completion
2019-10-16
Completion
2019-10-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule Oral

Indications