Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 1/17/2019 |
| Start Date: | February 2019 |
| End Date: | November 2021 |
| Contact: | Lisa Kornfeld, M.A. |
| Email: | lisa.kornfeld@ucdenver.edu |
| Phone: | 303-724-5324 |
A Randomized Pilot Study of Treatment for Subclinical Antibody-Mediated Rejection in Kidney Transplant Recipients
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.
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.
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, malignancies, etc.). 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. The
subjects will be randomized to either conversion from their current tacrolimus regimen to
Envarsus XR (a once a day, extended release version of tacrolimus); or, to a regimen of 5
plasma exchanges/IVIG (intravenous immunoglobulin) treatments and one treatment with
rituximab. Subjects who are within their first year of transplant will visit their doctor
monthly for regular tests and checks and then will have a kidney biopsy at 6 months. Subjects
who had their transplant over a year prior will see the doctor for tests and checks at 1, 3
and 5 months and then will have a biopsy of the kidney at month 6.
patients. Some of the current therapies used often come with dangerous complications
(infections, malignancies, etc.). 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. The
subjects will be randomized to either conversion from their current tacrolimus regimen to
Envarsus XR (a once a day, extended release version of tacrolimus); or, to a regimen of 5
plasma exchanges/IVIG (intravenous immunoglobulin) treatments and one treatment with
rituximab. Subjects who are within their first year of transplant will visit their doctor
monthly for regular tests and checks and then will have a kidney biopsy at 6 months. Subjects
who had their transplant over a year prior will see the doctor for tests and checks at 1, 3
and 5 months and then will have a biopsy of the kidney at month 6.
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
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
(303) 724-5000
Principal Investigator: James Cooper, M.D.
Phone: 303-724-3978
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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