Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen

Summary

THE INCIDENCE AND INFLUENTIAL FACTORS OF DSA IN CHINESE RENAL TRANSPLANT RECIPIENTS WITH MPA-BASED IMMUNOSUPPRESSIVE REGIMEN： A MULTI-CENTER CLINICAL STUDY (TIAIFOD STUDY) Study procedure Investigators at participating centers will identify patients fulfilling inclusion criteria and do not violate any exclusion criteria. Informed consent will be obtained upon entry into the study according to national regulations. Patients will be enrolled into the study and clinical data of patient history will be collected. Clinical data will be collected prospectively up to a total period of 12 months.

Timeline

Start

2021-01-22

Primary completion

2022-12-21

Completion

2023-12-31

Publications

• Results Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.
• Results Huang J, Millis JM, Mao Y, Millis MA, Sang X, Zhong S. Voluntary organ donation system adapted to Chinese cultural values and social reality. Liver Transpl. 2015 Apr;21(4):419-22. doi: 10.1002/lt.24069. Epub 2015 Feb 13.
• Results Miettinen J, Perasaari J, Lauronen J, Qvist E, Valta H, Pakarinen M, Merenmies J, Jalanko H. Donor-specific HLA antibodies and graft function in children after renal transplantation. Pediatr Nephrol. 2012 Jun;27(6):1011-9. doi: 10.1007/s00467-012-2101-4. Epub 2011 Oct 13.
• Results Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
• Results Ginevri F, Nocera A, Comoli P, Innocente A, Cioni M, Parodi A, Fontana I, Magnasco A, Nocco A, Tagliamacco A, Sementa A, Ceriolo P, Ghio L, Zecca M, Cardillo M, Garibotto G, Ghiggeri GM, Poli F. Posttransplant de novo donor-specific hla antibodies identify pediatric kidney recipients at risk for late antibody-mediated rejection. Am J Transplant. 2012 Dec;12(12):3355-62. doi: 10.1111/j.1600-6143.2012.04251.x. Epub 2012 Sep 7.
• Results Wiebe C, Gibson IW, Blydt-Hansen TD, Karpinski M, Ho J, Storsley LJ, Goldberg A, Birk PE, Rush DN, Nickerson PW. Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post kidney transplant. Am J Transplant. 2012 May;12(5):1157-67. doi: 10.1111/j.1600-6143.2012.04013.x. Epub 2012 Mar 19.
• Results Everly MJ, Rebellato LM, Haisch CE, Ozawa M, Parker K, Briley KP, Catrou PG, Bolin P, Kendrick WT, Kendrick SA, Harland RC, Terasaki PI. Incidence and impact of de novo donor-specific alloantibody in primary renal allografts. Transplantation. 2013 Feb 15;95(3):410-7. doi: 10.1097/TP.0b013e31827d62e3.
• Results Hidalgo LG, Campbell PM, Sis B, Einecke G, Mengel M, Chang J, Sellares J, Reeve J, Halloran PF. De novo donor-specific antibody at the time of kidney transplant biopsy associates with microvascular pathology and late graft failure. Am J Transplant. 2009 Nov;9(11):2532-41. doi: 10.1111/j.1600-6143.2009.02800.x.
• Results Wiebe C, Gibson IW, Blydt-Hansen TD, Pochinco D, Birk PE, Ho J, Karpinski M, Goldberg A, Storsley L, Rush DN, Nickerson PW. Rates and determinants of progression to graft failure in kidney allograft recipients with de novo donor-specific antibody. Am J Transplant. 2015 Nov;15(11):2921-30. doi: 10.1111/ajt.13347. Epub 2015 Jun 10.
• Results Cooper JE, Gralla J, Chan L, Wiseman AC. Clinical significance of post kidney transplant de novo DSA in otherwise stable grafts. Clin Transpl. 2011:359-64.
• Results DeVos JM, Patel SJ, Burns KM, Dilioglou S, Gaber LW, Knight RJ, Gaber AO, Land GA. De novo donor specific antibodies and patient outcomes in renal transplantation. Clin Transpl. 2011:351-8.
• Results de Kort H, Willicombe M, Brookes P, Dominy KM, Santos-Nunez E, Galliford JW, Chan K, Taube D, McLean AG, Cook HT, Roufosse C. Microcirculation inflammation associates with outcome in renal transplant patients with de novo donor-specific antibodies. Am J Transplant. 2013 Feb;13(2):485-92. doi: 10.1111/j.1600-6143.2012.04325.x. Epub 2012 Nov 21.
• Results Sharma A, Lewis JR, Lim WH, Palmer S, Strippoli G, Chapman JR, Alexander SI, Craig JC, Wong G. Renal transplant outcomes and de novo donor-specific anti-human leukocyte antigen antibodies: a systematic review. Nephrol Dial Transplant. 2018 Aug 1;33(8):1472-1480. doi: 10.1093/ndt/gfy077.
• Results O'Leary JG, Samaniego M, Barrio MC, Potena L, Zeevi A, Djamali A, Cozzi E. The Influence of Immunosuppressive Agents on the Risk of De Novo Donor-Specific HLA Antibody Production in Solid Organ Transplant Recipients. Transplantation. 2016 Jan;100(1):39-53. doi: 10.1097/TP.0000000000000869.
• Results Pratschke J, Dragun D, Hauser IA, Horn S, Mueller TF, Schemmer P, Thaiss F. Immunological risk assessment: The key to individualized immunosuppression after kidney transplantation. Transplant Rev (Orlando). 2016 Apr;30(2):77-84. doi: 10.1016/j.trre.2016.02.002. Epub 2016 Feb 18.
• Results Smith JM, Martz K, Blydt-Hansen TD. Pediatric kidney transplant practice patterns and outcome benchmarks, 1987-2010: a report of the North American Pediatric Renal Trials and Collaborative Studies. Pediatr Transplant. 2013 Mar;17(2):149-57. doi: 10.1111/petr.12034. Epub 2013 Jan 2.
• Results Filler G, Lepage N. To what extent does the understanding of pharmacokinetics of mycophenolate mofetil influence its prescription. Pediatr Nephrol. 2004 Sep;19(9):962-5. doi: 10.1007/s00467-004-1571-4. Epub 2004 Jul 15.
• Results Le Meur Y, Buchler M, Thierry A, Caillard S, Villemain F, Lavaud S, Etienne I, Westeel PF, Hurault de Ligny B, Rostaing L, Thervet E, Szelag JC, Rerolle JP, Rousseau A, Touchard G, Marquet P. Individualized mycophenolate mofetil dosing based on drug exposure significantly improves patient outcomes after renal transplantation. Am J Transplant. 2007 Nov;7(11):2496-503. doi: 10.1111/j.1600-6143.2007.01983.x. Epub 2007 Oct 1.
• Results Tonshoff B, David-Neto E, Ettenger R, Filler G, van Gelder T, Goebel J, Kuypers DR, Tsai E, Vinks AA, Weber LT, Zimmerhackl LB. Pediatric aspects of therapeutic drug monitoring of mycophenolic acid in renal transplantation. Transplant Rev (Orlando). 2011 Apr;25(2):78-89. doi: 10.1016/j.trre.2011.01.001. Epub 2011 Mar 30.
• Results Le Meur Y, Borrows R, Pescovitz MD, Budde K, Grinyo J, Bloom R, Gaston R, Walker RG, Kuypers D, van Gelder T, Kiberd B. Therapeutic drug monitoring of mycophenolates in kidney transplantation: report of The Transplantation Society consensus meeting. Transplant Rev (Orlando). 2011 Apr;25(2):58-64. doi: 10.1016/j.trre.2011.01.002. Epub 2011 Mar 30. No abstract available.
• Results Pawinski T, Hale M, Korecka M, Fitzsimmons WE, Shaw LM. Limited sampling strategy for the estimation of mycophenolic acid area under the curve in adult renal transplant patients treated with concomitant tacrolimus. Clin Chem. 2002 Sep;48(9):1497-504.
• Results Magee JC, Krishnan SM, Benfield MR, Hsu DT, Shneider BL. Pediatric transplantation in the United States, 1997-2006. Am J Transplant. 2008 Apr;8(4 Pt 2):935-45. doi: 10.1111/j.1600-6143.2008.02172.x.
• Results Chen B, Gu Z, Chen H, Zhang W, Fen X, Cai W, Fan Q. Establishment of high-performance liquid chromatography and enzyme multiplied immunoassay technology methods for determination of free mycophenolic acid and its application in Chinese liver transplant recipients. Ther Drug Monit. 2010 Oct;32(5):653-60. doi: 10.1097/FTD.0b013e3181f01397.
• Results Filler G, Todorova EK, Bax K, Alvarez-Elias AC, Huang SH, Kobrzynski MC. Minimum mycophenolic acid levels are associated with donor-specific antibody formation. Pediatr Transplant. 2016 Feb;20(1):34-8. doi: 10.1111/petr.12637. Epub 2015 Nov 21.
• Results Metzger RA, Delmonico FL, Feng S, Port FK, Wynn JJ, Merion RM. Expanded criteria donors for kidney transplantation. Am J Transplant. 2003;3 Suppl 4:114-25. doi: 10.1034/j.1600-6143.3.s4.11.x. No abstract available.
• Results Mallon DH, Summers DM, Bradley JA, Pettigrew GJ. Defining delayed graft function after renal transplantation: simplest is best. Transplantation. 2013 Nov 27;96(10):885-9. doi: 10.1097/TP.0b013e3182a19348.
• Results Czyzewski L, Wyzgal J, Czyzewska E, Kurowski A, Sierdzinski J, Labus A, Truszewski Z, Szarpak L. Performance of the MDRD, CKD-EPI, and Cockcroft-Gault Formulas in Relation to Nutritional Status in Stable Renal Transplant Recipients. Transplant Proc. 2016 Jun;48(5):1494-7. doi: 10.1016/j.transproceed.2016.01.083.
• Results Malheiro J, Tafulo S, Dias L, Martins LS, Fonseca I, Beirao I, Castro-Henriques A, Cabrita A. Analysis of preformed donor-specific anti-HLA antibodies characteristics for prediction of antibody-mediated rejection in kidney transplantation. Transpl Immunol. 2015 Mar;32(2):66-71. doi: 10.1016/j.trim.2015.01.002. Epub 2015 Feb 7.
• Results Haas M, Loupy A, Lefaucheur C, Roufosse C, Glotz D, Seron D, Nankivell BJ, Halloran PF, Colvin RB, Akalin E, Alachkar N, Bagnasco S, Bouatou Y, Becker JU, Cornell LD, Duong van Huyen JP, Gibson IW, Kraus ES, Mannon RB, Naesens M, Nickeleit V, Nickerson P, Segev DL, Singh HK, Stegall M, Randhawa P, Racusen L, Solez K, Mengel M. The Banff 2017 Kidney Meeting Report: Revised diagnostic criteria for chronic active T cell-mediated rejection, antibody-mediated rejection, and prospects for integrative endpoints for next-generation clinical trials. Am J Transplant. 2018 Feb;18(2):293-307. doi: 10.1111/ajt.14625. Epub 2018 Jan 21.
• Results van Gelder T, Silva HT, de Fijter JW, Budde K, Kuypers D, Tyden G, Lohmus A, Sommerer C, Hartmann A, Le Meur Y, Oellerich M, Holt DW, Tonshoff B, Keown P, Campbell S, Mamelok RD. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation. 2008 Oct 27;86(8):1043-51. doi: 10.1097/TP.0b013e318186f98a.

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