A multicenter, randomized, open-labeled study to steer immunosuppressive and antiviral therapy by measurement of virus (CMV, ADV, HSV)-specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients (IVIST01-trial): Study protocol for a randomized controlled trial

Trials

Volumn 15, Issue 1, 2014, Pages

  Ahlenstiel Grunow, Thurid ^a   Koch, Armin ^a   Großhennig, Anika ^a   Frömke, Cornelia ^a,b   Sester, Martina ^c   Sester, Urban ^c   Schröder, Christoph ^a   Pape, Lars ^a  

^a HANNOVER MEDICAL SCHOOL   (Germany)

^b UNIVERSITY OF VETERINARY MEDICINE HANNOVER   (Germany)

^c SAARLAND UNIVERSITY   (Germany)

Author keywords

Antiviral therapy; Cytomegalovirus; Drug monitoring; Immunomonitoring; Immunosuppression; Kidney transplantation; Over immunosuppression; Pediatric transplantation; Personalized immunosuppressive therapy; Viral infections; Virus specific T cells

Indexed keywords

ANTIVIRUS AGENT; BASILIXIMAB; CYCLOSPORIN A; EVEROLIMUS; PREDNISOLONE; VALGANCICLOVIR; IMMUNOSUPPRESSIVE AGENT;

ADENOVIRUS INFECTION; ADOLESCENT; ARTICLE; CD4+ T LYMPHOCYTE; CHILD; CONTROLLED STUDY; CORRELATION ANALYSIS; CYTOKINE PRODUCTION; CYTOMEGALOVIRUS INFECTION; DISEASE SEVERITY; EVENING DOSAGE; FEMALE; FLOW CYTOMETRY; FLUORESCENCE ACTIVATED CELL SORTING; GLOMERULUS FILTRATION RATE; HERPES SIMPLEX; HUMAN; IMMUNOLOGICAL TOLERANCE; IMMUNOSUPPRESSIVE TREATMENT; INFANT; KIDNEY FUNCTION; KIDNEY TRANSPLANTATION; LIQUID CHROMATOGRAPHY; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; NEPHROTOXICITY; PROCESS OPTIMIZATION; RANDOMIZED CONTROLLED TRIAL; RECOMMENDED DRUG DOSE; SEROLOGY; SINGLE DRUG DOSE; T LYMPHOCYTE; T LYMPHOCYTE ACTIVATION; TANDEM MASS SPECTROMETRY; UPREGULATION; VIRUS LOAD; VIRUS REPLICATION; ALLOTRANSPLANTATION; BLOOD; CLINICAL PROTOCOL; CLINICAL TRIAL; CYTOMEGALOVIRUS; DRUG MONITORING; HUMAN ADENOVIRUS C; IMMUNOLOGY; SAMPLE SIZE; SIMPLEXVIRUS;

ADENOVIRUSES, HUMAN; ANTIVIRAL AGENTS; CHILD; CLINICAL PROTOCOLS; CYTOMEGALOVIRUS; DRUG MONITORING; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; SAMPLE SIZE; SIMPLEXVIRUS; T-LYMPHOCYTES; TRANSPLANTATION, HOMOLOGOUS;

EID: 84934283020     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-15-324     Document Type: Article

References (18)

1. Preiksaitis JK, Brennan DC, Fishman J, Allen U: Canadian Society of Transplantation consensus workshop on cytomegalovirus management in solid organ transplantation final report. Am J Transplant 2005, 5:218-227. 10.1111/j.1600-6143.2004.00692.x.
2. Sester M, Sester U, Gärtner B, Heine G, Girndt M, Mueller-Lantzsch N, Meyerhans A, Köhler H: Levels of virus-specific CD4 T cells correlate with cytomegalovirus control and predict virus-induced disease after renal transplantation. Transplantation 2001, 71:1287-1294. 10.1097/00007890-200105150-00018.
3. Sester U, Gärtner BC, Wilkens H, Schwaab B, Wössner R, Kindermann I, Girndt M, Meyerhans A, Mueller-Lantzsch N, Schäfers H-J, Sybrecht GW, Köhler H, Sester M: Difference in CMV-specific T-cell levels and long-term susceptibility to CMV infection after kidney, heart and lung transplantation. Am J Transplant 2005, 5:1483-1489. 10.1111/j.1600-6143.2005.00871.x.
4. Radha R, Jordan S, Puliyanda D, Bunnapradist S, Petrosyan A, Amet N, Toyoda M: Cellular immune responses to cytomegalovirus in renal transplant recipients. Am J Transplant 2005, 5:110-117. 10.1111/j.1600-6143.2003.00647.x.
5. Tu W, Potena L, Stepick-Biek P, Liu L, Dionis KY, Luikart H, Fearon WF, Holmes TH, Chin C, Cooke JP, Valantine HA, Mocarski ES, Lewis DB: T-cell immunity to subclinical cytomegalovirus infection reduces cardiac allograft disease. Circulation 2006, 114:1608-1615. 10.1161/CIRCULATIONAHA.105.607549.
6. Gamadia LE, Remmerswall EB, Weel JF, Bemelman F, van Lier RA, ten Berge IJ: Primary immune responses to human CMV: a critical role for IFN-g-producing CD4+ T cells in protection against CMV disease. Blood 2003, 101:2686-2692. 10.1182/blood-2002-08-2502.
7. Gamadia LE, Rentenaar RJ, van Lier RA, ten Berge IJ: Properties of CD4+ T cells in human cytomegalovirus infection. Human Immunol 2004, 65:486-492. 10.1016/j.humimm.2004.02.020.
8. Sester M, Sester U, Gärtner BC, Girndt M, Meyerhans A, Köhler H: Dominance of virus-specific CD8 T cells in human primary cytomegalovirus infection. J Am Soc Nephrol 2002, 13:2577-2584. 10.1097/01.ASN.0000030141.41726.52.
9. Sester M, Gärtner BC, Sester U, Girndt M, Mueller-Lantzsch N, Köhler H: Is the cytomegalovirus serologic status always accurate? A comparative analysis of humoral and cellular immunity. Transplantation 2003, 76:1229-1230. 10.1097/01.TP.0000083894.61333.56.
10. Engstrand M, Lidehäll AK, Tötterman TH, Herrman B, Eriksson BM, Korksgren O: Cellular responses to cytomegalovirus in immunosuppressed patients: circulating CD8+ T cells recognizing CMVpp65 are present but display functional impairment. Clin Exp Immunol 2003, 132:96-104. 10.1046/j.1365-2249.2003.02098.x.
11. Gamadia LE, Rentenaar RJ, Baars PA, Remmerswaal EB, Surachno S, Weel JF, Toebes M, Schumacher TN, ten Berge IJ, van Lier RA: Differentiation of cytomegalovirus-specific CD8+ T cells in healthy and immunosuppressed virus carriers. Blood 2001, 98:754-761. 10.1182/blood.V98.3.754.
12. Rentenaar RJ, Gamadia LE, van der Hoek N, van Diepen FN, Boom R, Weel JF, Wertheim-van Dillen PM, van Lier RA, ten Berge IJ: Development of virus-specific CD4+ T cells during primary cytomegalovirus infection. J Clin Invest 2000, 105:541-548. 10.1172/JCI8229.
13. Bunde T, Kirchner A, Hoffmeister B, Habedank D, Hetzer R, Cherepnev G, Proesch S, Reinke P, Volk HD, Lehmkuhl H, Kern F: Protection from cytomegalovirus after transplantation is correlated with immediate early 1-specific CD8 T cells. J Exp Med 2005, 201:1031-1036. 10.1084/jem.20042384.
14. La Rosa C, Limaye AP, Krishnan A, Longmate J, Diamond DJ: Longitudinal assessment of cytomegalovirus (CMV)-specific immune responses in liver transplant recipients at high risk for late CMV disease. J Infect Dis 2007, 195:633-644. 10.1086/511307.
15. Sester M, Sester U, Alarcon Salvador S, Heine G, Lipfert S, Girndt M, Gärtner B, Köhler H: Age-related decrease in adenovirus-specific T cell responses. J Infec Dis 2002, 185:1379-1387. 10.1086/340502.
16. Olive M, Eisenlohr LC, Flomenberg P: Quantitative analysis of adenovirus-specific CD4+ T-cell responses from healthy adults. Viral Immunol 2001, 14:403-413. 10.1089/08828240152716646.
17. Ginevri F, Azzi A, Hirsch HH, Basso S, Fontana I, Cioni M, Bodaghi S, Salotti V, Rinieri A, Botti G, Perfumo F, Locatelli F, Comoli P: Prospective monitoring of polyomavirus BK replication and impact of pre-emptive intervention in pediatric kidney recipients. Am J Transplant 2007, 7:2727-2735. 10.1111/j.1600-6143.2007.01984.x.
18. Regulation (EC) No 141/2000 of the European parliament and of the council of 16 December 1999 on orphan medicinal products Official Journal of the European Communities 2010, L18/1-L18/5.