Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients
Stopped early · Early Phase 1
Conditions studied: Kidney Transplant Rejection
In brief
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.
Key facts
- Study ID
- NCT03380936
- Run by
- University of Colorado, Denver
- People needed
- 4
- Starts
- 2018-01-17
- Expected to finish
- 2019-10-16
- Last updated by the study team
- 2020-10-27
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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