Prospective, Randomized Pilot Study of B-Cell Targeted Induction Therapy in Sensitized Kidney Transplant Recipients: Final Report, A
U of Cincinnati, Cincinnati
The Christ Hospital, Cincinnati
Meeting: 2013 American Transplant Congress
Abstract number: 175
Optimal induction therapy for patients at high risk for antibody and/or cell mediated rejection has not been established. This study evaluated addition of B-cell targeting agents to rATG induction in a high risk renal transplant population.
Methods: High immunologic risk was defined as either: 1)Current cytotoxic PRA ≥20% or peak ≥50% 2)T or B-cell positive flow crossmatch (XM) with donor specific antibody (DSA) 3)Historical positive cytotoxic XM or DSA or 4)Prior allograft loss to acute rejection (AR). Immunosuppression included tacrolimus, mycophenolate, and steroids. Patients were randomized to: rATG, rATG+rituximab (rATG+R), rATG+bortezomib (rATG+B), or rATG+rituximab+bortezomib (rATG+R+B) for induction.
Results: Results are presented in the table.
| rATG (N=10) | rATG + R (N=10) | rATG + B (N=10) | rATG + R + B (N=10) | |
| Mean age (years) | 49.6 ± 7.7 | 52.2 ± 10.8 | 49.2 ± 15.2 | 49.0 ± 10.5 |
| Female | 5 (50%) | 5 (50%) | 8 (80%) | 4 (40%) |
| African American | 5 (50%) | 4 (40%) | 1 (10%) | 1 (10%) |
| Living donor transplant | 6 (60%) | 7 (70%) | 6 (60%) | 5 (50%) |
| Follow-up (days, mean ± SD, median) | 721.6 ± 288.8, 719 | 661.4 ± 307.5, 599 | 595.4 ± 386.9, 459 | 529.4 ± 327.5, 492 |
| Repeat transplant | 4 (40%) | 2 (20%) | 3 (30%) | 6 (60%) |
| Mean current cytotoxic PRA | 25.0 ± 33.9 | 24.2 ± 33.5 | 28.6 ± 32.7 | 32.0 ± 39.8 |
| Preexisting DSA | 5 (50%) | 5 (50%) | 5 (50%) | 6 (60%) |
| AR rate | 2 (20%) | 1 (10%) | 5 (50%) | 3 (30%) |
| AR due to noncompliance | 0 | 0 | 1 (10%) | 1 (10%) |
| De novo DSA | 3 (30%) | 3 (30%) | 1 (10%) | 3 (30%) |
| Patient survival | 9 (90%) | 9 (90%) | 10 (100%) | 9 (90%) |
| Graft survival | 9 (90%) | 9 (90%) | 8 (80%) | 9 (90%) |
| Death-censored graft survival | 10 (100%) | 10 (100%) | 8 (80%) | 10 (100%) |
| Mean baseline SCr (mg/dL) | 8.7 ± 2.4 | 7.1 ± 2.5 | 5.9 ± 2.7 | 10.2 ± 3.0 |
| Mean 1 year SCr (mg/dL) | 1.4 ± 0.4 | 1.4 ± 0.3 | 1.8 ± 1.3 | 1.3 ± 0.2 |
Three deaths with functioning grafts occurred from MI, unknown cause, and systemic lupus vasculitis. Two graft losses occurred in the rATG+B group due to noncompliance and antibody-mediated rejection due to preexisting DP antibody. Malignancies inc
To cite this abstract in AMA style:
Ejaz N, Shields A, Alloway R, Sadaka B, Girnita A, Mogilishetty G, Kremer J, Cardi M, Woodle E. Prospective, Randomized Pilot Study of B-Cell Targeted Induction Therapy in Sensitized Kidney Transplant Recipients: Final Report, A [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/prospective-randomized-pilot-study-of-b-cell-targeted-induction-therapy-in-sensitized-kidney-transplant-recipients-final-report-a/. Accessed November 23, 2024.« Back to 2013 American Transplant Congress