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611.
Peter W. Nickerson Robert Balshaw Chris Wiebe Julie Ho Ian W. Gibson Nancy D. Bridges David N. Rush Peter S. Heeger 《American journal of transplantation》2021,21(4):1503-1512
Improving long-term kidney transplant outcomes requires novel treatment strategies, including delayed calcineurin inhibitor (CNI) substitution, tested using informative trial designs. An alternative approach to the usual superiority-based trial is a noninferiority trial design that tests whether an investigational agent is not unacceptably worse than standard of care. An informative noninferiority design, with biopsy-proven acute rejection (BPAR) as the endpoint, requires determination of a prespecified, evidence-based noninferiority margin for BPAR. No such information is available for delayed CNI substitution in kidney transplantation. Herein we analyzed data from recent kidney transplant trials of CNI withdrawal and “real world” CNI- based standard of care, containing subjects with well-documented evidence of immune quiescence at 6 months posttransplant—ideal candidates for delayed CNI substitution. Our analysis indicates an evidence-based noninferiority margin of 13.8% for the United States Food and Drug Administration's composite definition of BPAR between 6 and 24 months posttransplant. Sample size estimation determined that ~225 randomized subjects would be required to evaluate noninferiority for this primary clinical efficacy endpoint, and superiority for a renal function safety endpoint. Our findings provide the basis for future delayed CNI substitution noninferiority trials, thereby increasing the likelihood they will provide clinically implementable results and achieve regulatory approval. 相似文献
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Chaohong Zhu Wenyu Xiang Bingjue Li Yucheng Wang Shi Feng Cuili Wang Ying Chen Wenqing Xie Lihui Qu Hongfeng Huang Francesco Annunziata Suneetha Nunna Anna Krepelova Seyed Mohammad M. Rasa Francesco Neri Jianghua Chen Hong Jiang 《American journal of transplantation》2021,21(2):567-581
Acute rejection (AR) can lead to allograft dysfunction following renal transplantation, despite immunosuppressive treatments. Accumulating evidence points out a role for epigenetic modification in immune responses. However, the mechanism and contribution of DNA methylation in allograft survival remain unclear. In this study, we followed up patients who successively experienced end-stage renal disease, renal transplantation with allograft function or dysfunction, and hemodialysis. Peripheral blood mononuclear cells were collected at different time points for analysis of the DNA methylation. Epigenetic modifier analysis was also performed to explore its effect of methylation in a mouse model of AR. Compared with the allograft-stable cohort, patients who experienced AR-induced allograft dysfunction demonstrated more changes in methylation patterns. Pathway analysis revealed that the hypermethylated areas in the allograft dysfunction group were associated with genes related to the mechanistic target of rapamycin (mTOR) signaling pathway. Moreover, in the mouse AR model, treatment with the DNA methyltransferase inhibitor—decitabine regulated the Th1/2/17/regulatory T cell (Treg cell) immune response via its demethylating role in the suppressing the activity of the mTOR pathway, which ultimately ameliorated renal allograft-related inflammatory injuries. These results revealed that changes in methylation accompany AR-induced allograft dysfunction after renal transplantation. Epigenetics may provide new insights into predicting and improving allograft survival. 相似文献
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Elham Behrangi Afsaneh SadeghzadehBazargan Nastaran Salimi Zoha Shaka Mohammad Hosein Feyz Kazemi Azadeh Goodarzi 《Clinical Case Reports》2022,10(4)
The COVID‐19 pandemic has been extra challenging for patients with chronic diseases. Psoriasis is one of the chronic conditions that its treatment mostly relies on immunosuppressants. In this study, we report two cases with a long history of psoriasis that COVID‐19 infection caused them to undergo erythrodermic psoriasis. 相似文献
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