Assessment of efficacy and safety of FK778 in comparison with standard care in renal transplant recipients with untreated BK nephropathy

Transplantation

Volumn 90, Issue 8, 2010, Pages 891-897

  Guasch, Antonio ^a   Roy Chaudhury, Prabir ^b   Woodle, E Steve ^b   Fitzsimmons, William ^c   Holman, John ^c   First, M Roy ^c  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^c ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

Author keywords

BK nephropathy; FK778; Kidney transplantation

Indexed keywords

CYCLOSPORIN A; MANITIMUS; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; TACROLIMUS; 2 CYANO 3 HYDROXY N (4 (TRIFLUOROMETHYL)PHENYL) 2 HEPTEN 6 YNAMIDE; 2-CYANO-3-HYDROXY-N-(4-(TRIFLUOROMETHYL)PHENYL)-2-HEPTEN-6-YNAMIDE; ALKYNE; CREATININE; CYCLOSPORIN; DRUG DERIVATIVE; IMMUNOSUPPRESSIVE AGENT; ISOXAZOLE DERIVATIVE; MYCOPHENOLIC ACID; NITRILE;

ANEMIA; ARTHRALGIA; ARTICLE; ASEPTIC NECROSIS; BACKACHE; BACTERIAL INFECTION; BK VIRUS; BLURRED VISION; BRONCHITIS; CHRONIC ALLOGRAFT NEPHROPATHY; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONTUSION; COUGHING; CREATININE BLOOD LEVEL; DEMOGRAPHY; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; DYSPNEA; ESCHERICHIA COLI INFECTION; FATIGUE; FEMALE; FEVER; FOOT PAIN; GLOMERULONEPHRITIS; GOITER; GRAFT RECIPIENT; HEADACHE; HEMATURIA; HUMAN; HUMAN TISSUE; HYPERGLYCEMIA; HYPERLIPIDEMIA; HYPERTENSION; HYPOGLYCEMIA; HYPOKALEMIA; HYPOTENSION; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY BIOPSY; KIDNEY FAILURE; KIDNEY FUNCTION; KIDNEY GRAFT REJECTION; KIDNEY INFECTION; KIDNEY TRANSPLANTATION; LEUKOPENIA; LIMB PAIN; LIVER FUNCTION TEST; LOADING DRUG DOSE; LOOSE FECES; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; MYALGIA; NAUSEA; NOCTURIA; OPEN STUDY; PARALLEL DESIGN; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; RETICULOCYTOSIS; RHINOPHARYNGITIS; SIDE EFFECT; SINUSITIS; SKIN BRUISING; SKIN CARCINOMA; THROMBOCYTOPENIA; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VIRUS INFECTION; VIRUS LOAD; VOMITING; WEIGHT; ALGORITHM; BLOOD; FOLLOW UP; GRAFT REJECTION; IMMUNOLOGY; PATHOLOGY; PATIENT COMPLIANCE; POLYOMAVIRUS INFECTION; TIME;

ALGORITHMS; ALKYNES; CREATININE; CYCLOSPORINE; FOLLOW-UP STUDIES; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; ISOXAZOLES; KIDNEY TRANSPLANTATION; MYCOPHENOLIC ACID; NITRILES; PATIENT COMPLIANCE; POLYOMAVIRUS INFECTIONS; SIROLIMUS; TACROLIMUS; TIME FACTORS; VIRAL LOAD;

EID: 78349279503     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e3181f2c94b     Document Type: Article

References (26)

1. Hariharan S. BK virus nephritis after renal transplantation. Kidney Int 2006; 69: 655.
2. Trofe J, Hirsch HH, Ramos E. Polyomavirus-associated nephropathy: Update of clinical management in kidney transplant patients. Transpl Infect Dis 2006; 8: 76.
3. Trofe J, Gordon J, Roy-Chaudhury P, et al. Polyomavirus nephropathy in kidney transplantation. Prog Transplant 2004; 14: 130.
4. Ramos E, Drachenberg CB, Wali R, et al. The decade of polyomavirus BK-associated nephropathy: State of affairs. Transplantation 2009; 87: 621.
5. Buehrig CK, Lager DJ, Stegall MD, et al. Influence of surveillance renal allograft biopsy on diagnosis and prognosis of polyomavirus-associated nephropathy. Kidney Int 2003; 64: 665.
6. Stolt A, Sasnauskas K, Koskela P, et al. Seroepidemiology of the human polyomaviruses. J Gen Virol 2003; 84(pt 6): 1499.
7. Prince O, Savic S, Dickenmann M, et al. Risk factors for polyoma virus nephropathy. Nephrol Dial Transplant 2009; 24: 1024.
8. Koch MJ, Bohl DL, Miller BW, et al. Long term (median 5-year) follow-up of preemptive immunosuppression reduction for BK vire-mia [abstract]. Am J Transplant 2007; 7(suppl 2): 151.
9. Saad ER, Bresnahan BA, Cohen EP, et al. Successful treatment of BK viremia using reductionin immunosuppression without antiviral therapy. Transplantation 2008; 85: 850.
10. Wadei HM, Rule AD, Lewin M, et al. Kidney transplant function and histological clearance of virus following diagnosis of polyomavirus-associated nephropathy (PVAN). Am J Transplant 2006; 6(pt 1): 1025.
11. Brennan DC, Agha I, Bohl DL, et al. Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction. Am J Transplant 2005; 5: 582.
12. Kim HC, Hwang EA, Han SY, et al. Polyomavirus nephropathy after renal transplantation: A single centre experience. Nephrology 2005; 10: 198.
13. Vasudev B, Hariharan S, Hussain SA, et al. BK virus nephritis: Risk factors, timing, and outcome in renal transplant recipients. Kidney Int 2005; 68: 1834.
14. Williams JW, Javaid B, Kadambi PV, et al. Leflunomide for polyoma-virus type BK nephropathy. N Engl J Med 2005; 352: 1157.
15. Josephson MA, Gillen D, Javaid B, et al. Treatment of renal allograft poly-oma BK virus infection with leflunomide. Transplantation 2006; 81: 704.
16. Farasati NA, Shapiro R, Vats A, et al. Effect of leflunomide and cidofo-vir on replication of BK virus in an in vitro culture system. Transplantation 2005; 79: 116.
17. Waldman WJ, Knight DA, Blinder L, et al. Inhibition of cytomegalovi-rus in vitro and in vivo by the experimental immunosuppressive agent leflunomide. Intervirology 1999; 42: 412.
18. Faguer S, Hirsch HH, Kamar N, et al. Leflunomide treatment for poly-omavirus BK-associated nephropathy after kidney transplantation. Transpl Int 2007; 20: 962.
19. Schorlemmer HU. Development of a novel drug for transplantation: Current results and future perspectives. Transplant Proc 2001; 33: 2425.
20. Zeng H, Waldman WJ, Yin DP, et al. Mechanistic study of malononi-trileamide FK778 in cardiac transplantation and CMV infectionin rats. Transplantation 2005; 79: 17.
21. Evers DL, Wang X, Huong SM, et al. Inhibition of human cytomega-lovirus signaling and replication by the immunosuppressant FK778. Antiviral Res 2005; 65: 1.
22. Snoeck R, Andrei G, Lilja H, et al. Activity of malononitrilamide compounds against murine and simian polyomavirus [abstract]. Presented at the 5th International Conference on New trends in Clinical and Experimental Immunosuppression, Geneva, Switzerland, 2002.
23. Vanrenterghem Y, van Hooff JP, Klinger M, et al. The effects of Fk778 in combination with tacrolimus and steroids: A phase II multicenter study in renal transplant patients. Transplantation 2004; 78: 9.
24. Johnston O, Jaswal D, Gill JS, et al. Treatment of polyomavirus infection in kidney transplant recipients: A systematic review. Transplantation 2010; 89: 1057.
25. Dall A,HariharanS. BKvirus nephritis after renal transplantation. Clin J Am Soc Nephrol 2008; 3(suppl 2): S68.
26. Leca N, Muczynski KA, Jefferson JA, et al. Higher levels of leflunomide are associated with hemolysis and are not superior to lower levels for BK virus clearance in renal transplant patients. Clin J Am Soc Nephrol 2008; 3: 829.