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BPARBiopsy-Proven Acute Rejection
BPARBlack-Pigmented Anaerobic Rods (dentistry)
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ECDs as a result of DCD and donation after brain death are defined separately for kidneys according to the United Network for Organ Sharing definition.[4] The recipients of ECD kidneys are often excluded from transplant trials due to the higher rate of delayed graft function (DGF), more biopsy-proven acute rejection (BPAR), decreased long-term graft function, calcineurin inhibitor (CNI)-induced nephrotoxicity, increased incidence of infection, cardiovascular risk, and malignancies.[5],[6] For this reason, the ideal immunosuppressive regimen for this population has not yet been defined.
Tacrolimus C [sub]0 and the risk of biopsy-proven acute rejection
Abbreviations ATN: Acute tubular necrosis BMI: Body mass index BPAR: Biopsy-proven acute rejection CMV: Cytomegalovirus CNI: Calcineurin inhibitor CsA: Cyclosporine DCD: Donation after circulatory death DGF: Delayed graft function dnDSA: De novo donor specific antibodies DSA: Donor specific antibodies ECD: Expanded criteria donor IRI: Ischemia-reperfusion Injury IL-2RA: Interleukin-2 receptor antagonist L-FABP: L-type fatty acid binding protein MFI: Mean fluorescence intensity MMF: Mycophenolate mofetil NAGL: Neutrophil gelatinase-associated lipocalin OPTN: Organ Procurement and Transplant PRA: Panel reactive antibody PTLD: Posttransplant lymphoproliferative disease rATG: Rabbit antithymocyte globulin (Thymoglobuline).
Abbreviations ADV: Adenovirus ANA: Antinuclear antibody BPAR: Biopsy-proven acute rejection DSA: Donor-specific HLA-antibody HCMV: Human cytomegalovirus DMSO: Dimethylsulfoxide DSMB: Data safety monitoring board EBV: Epstein-Barr virus INR: International normalized ratio IS: Immunosuppression ICU: Intensive care unit ISCT: International Society of Cellular Therapy LDLT: Living-donor liver transplantation LKMA: Anti-liver-kidney microsomal antibody LT: Liver transplantation MDSC: Myeloid-derived immunosuppressive cell MSC: Mesenchymal stem (stromal) cell pLT: Pediatric liver transplantation RI: Resistance index RT-PCR: Reverse transcription polymerase chain reaction TA Vmax: Time-averaged maximum velocity SAE: Severe adverse event SMA: Anti-smooth muscle antibody.
Novartis says the results of Phase III clinical trial (n=729) showed a two-dose regimen of Simulect, used concomitantly with cyclosporine for microemulsion and corticosteroids, proportionately reduced the incidence of biopsy-proven acute rejection by nearly one-third (31% incidence with Simulect; 45% with placebo) during the first six months post transplant.
Treatment failure was a composite endpoint that included death, graft failure, biopsy-proven acute rejection or lost to follow-up.
Biopsy-proven acute rejection episodes occurred in non-African-American patients in the first three months, while the incidence of acute rejection in African-American patients continued to increase throughout the first year (Padiyar et al., 2010).
The primary efficacy endpoint was a composite of death, graft failure, biopsy-proven acute rejection (BPAR) via a local pathology reading or loss to follow-up within 12 months of randomisation.