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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. 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., For this reason, the ideal immunosuppressive regimen for this population has not yet been defined.
End points studied were as follows: (1) patient survival at 1st year, (2) graft survival at 1st year, (3) DGF, (4) 1-year serum creatinine and estimated glomerular filtration rate (eGFR), and (5) the BPAR rate in the 1st year.
Rates of BPAR and steroid-resistant BPAR were also significantly lower under rATG  (Table 2).
Nonrandomized trials have also shown lower rates of DGF and BPAR compared to IL-2RA induction when rATG is started intraoperatively in patients at high immunological risk [68,69], with mixed evidence for a benefit for DGF when rATG is initiated after surgery in mixed-risk populations [11, 70] or in low- or moderate-risk populations even if the first dose of rATG is given before reperfusion .
The composite endpoint was considered when BPAR was absent and eGFR [greater than or equal to] 60 mL/min/1.73[m.sub.2] was present.
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.
Earlier, the Finance Minister distributed BPAR Awards and Certificates of Merit among the representatives of selected firms and companies.
BPAR occurred in 37 of the 185 patients, 4 of whom carried CYP3A4 intron 6 variant T, but no significant differences in BPAR incidence were observed between carriers of the T variant and CC patients [[chi square] (1) = 1.42; P = 0.23].
In another retrospective study assessing conversion (medium quality), BPAR among patients converted at various times was 3.4% , while a medium quality review of a prospectively maintained database revealed an acute cellular rejection rate of 17.2% for those treated de novo with sirolimus versus 2.8% for those converted at various timepoints to sirolimus in response to rising serum creatinine concentrations .
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.
CTI says the primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes in patients receiving ISA247 for six months compared to the tacrolimus control.
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