Status:
TERMINATED
Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18-79 years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
There is currently minimal data to guide treatment of mild graft damage in kidney transplant patients. Some of the current therapies used often come with dangerous complications (infections, malignanc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03380936
Start Date
January 17 2018
End Date
October 16 2019
Last Update
October 27 2020
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045