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

• Status: Terminated
• Trial end date: 2019-10-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Tacrolimus

Criteria

Inclusion Criteria:

• Adult (18+ years) recipients of kidney or kidney/pancreas transplants

• Willing to sign an IRB (institutional review board)-approved consent and to comply with study requirements

• DSA (donor specific antibodies) detected by SAB (single antigen beads) screening with MFI ≥ 2000

• Graft biopsy performed within prior 30 days

• Stable renal function defined by serum creatinine increase ≤ 30% over prior 6 months

• Subacute antibody-mediated rejection on biopsy defined by ptc + g + C4d ≥ 2 by Banff 2013 criteria

Exclusion Criteria:

• Kidney/liver or kidney/heart recipient

• Unwilling/unable to undergo screening biopsy

• HIV (human immunodeficiency virus), HCV (hepatitis-C virus), or HBsAg (hepatitis-B surface antigen) positive

• Active/untreated infection

• Acute cellular rejection with Banff grade 1b, 2a, 2b on initial biopsy requiring rATG (rabbit anti-thymocyte globulin) therapy

• Pregnant or nursing females