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

EARLY_PHASE1TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

January 17, 2018

Primary Completion Date

October 16, 2019

Study Completion Date

October 16, 2019

Conditions
Kidney Transplant Rejection
Interventions
DRUG

Tacrolimus Extended Release Oral Tablet [Envarsus]

Switching from current version of tacrolimus to the extended release, once a day version (Envarsus) and titrating dose to achieve an optimal trough level. Goal trough tac level \> 8 ng/ml, MPA at 720 mg bid unless medically contraindicated, prednisone at current dose (5mg) or continue taper to 5mg per center standard of care protocol.

OTHER

Plasma Exchange and IVIG (Intravenous Immunoglobulin )

Plasma exchange x 5 treatments, each followed by IVIG 200 mg/kg except last dose of 1 gm/kg. Rituximab 375 mg/m2 following final plasma exchange treatment.

Trial Locations (1)

80045

University of Colorado Anschutz Medical Campus, Aurora

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Veloxis Pharmaceuticals

INDUSTRY

lead

University of Colorado, Denver

OTHER