RPSGL-Ig for improvement of early liver allograft function: A double-blind, placebo-controlled, single-center phase II study

American Journal of Transplantation

Volumn 11, Issue 4, 2011, Pages 786-797

  Busuttil, R W ^a   Lipshutz, G S ^a   Kupiec Weglinski, J W ^a   Ponthieux, S ^a   Gjertson, D W ^a   Cheadle, C ^b   Watkins, T ^b   Ehrlich, E ^b   Katz, E ^c   Squiers, E C ^d   Rabb, H ^b   Hemmerich, S ^e  

^a UCLA MEDICAL CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c CTI Clinical Trial and Consulting Services   (United States)

^d Pacific Biodevelopment LLC   (United States)

^e Y's Therapeutics Inc   (United States)

Author keywords

Clinical trial; ischemia reperfusion injury; liver transplantation; selectin antagonist

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BETA INTERFERON; BILIRUBIN; GAMMA INTERFERON; GAMMA INTERFERON INDUCIBLE PROTEIN 10; HEME OXYGENASE 1; HIGH MOBILITY GROUP B1 PROTEIN; IMMUNOGLOBULIN G; IMMUNOGLOBULIN G ANTIBODY; INTERLEUKIN 10; INTERLEUKIN 6; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; P SELECTIN GLYCOPROTEIN LIGAND 1; PLACEBO; PROTEIN BCL 2; RECOMBINANT P SELECTIN GLYCOPROTEIN LIGAND 1 IMMUNOGLOBULIN G; RECOMBINANT PROTEIN; STEROID; TACROLIMUS; TOLL LIKE RECEPTOR 4; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ACUTE GRAFT REJECTION; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTERY THROMBOSIS; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BLEEDING; BLOOD DISEASE; CADAVER DONOR; CLINICAL ARTICLE; CLINICAL PROTOCOL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; GRAFT FAILURE; GRAFT RECIPIENT; GRAFT SURVIVAL; HEART DISEASE; HEPATIC ARTERY THROMBOSIS; HOSPITALIZATION; HUMAN; HUMAN TISSUE; IMMUNOGENICITY; IMMUNOPATHOLOGY; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; INFESTATION; KIDNEY DISEASE; LENGTH OF STAY; LIVER FUNCTION; LIVER GRAFT; LIVER GRAFT REJECTION; LIVER ISCHEMIA; LIVER TRANSPLANTATION; LYMPHATIC SYSTEM DISEASE; MALE; MAXIMUM PLASMA CONCENTRATION; MEDIASTINUM DISEASE; METABOLIC DISORDER; NEUROLOGIC DISEASE; NUTRITIONAL DISORDER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REPERFUSION INJURY; RESPIRATORY TRACT DISEASE; RISK FACTOR; SKIN DISEASE; THORAX DISEASE; TREATMENT OUTCOME; URINARY TRACT DISEASE;

ADULT; AGED; DOUBLE-BLIND METHOD; FEMALE; GRAFT REJECTION; HUMANS; INTERLEUKIN-10; LIVER FUNCTION TESTS; LIVER TRANSPLANTATION; MALE; MEMBRANE GLYCOPROTEINS; MIDDLE AGED; RECOMBINANT PROTEINS; REPERFUSION INJURY; TRANSPLANTATION, HOMOLOGOUS;

EID: 79953244190     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2011.03441.x     Document Type: Article

References (34)

1. Carter YM, Davis RD,. Primary graft dysfunction in lung transplantation. Semin Respir Crit Care Med 2006; 27: 501-507. (Pubitemid 44672553)
2. Dulkanchainun TS, Goss JA, Imagawa DK, et al,. Reduction of hepatic ischemia/reperfusion injury by a soluble P-selectin glycoprotein ligand-1. Ann Surg 1998; 227: 832-840. (Pubitemid 29119530)
3. Goes N, Urmson J, Ramassar V, Halloran PF,. Ischemic acute tubular necrosis induces an extensive local cytokine response. Evidence for induction of interferon-gamma, transforming growth factor-beta 1, granulocyte-macrophage colony-stimulating factor, interleukin-2, and interleukin-10. Transplantation 1995; 59: 565-572.
4. Kusaka M, Nadeau KC, Takada M, Nagano H, Shaw GD, Tilney NL,. Influence of initial antigen-independent events on acute allograft rejection: Inhibition by a soluble P-selectin ligand and low-dose cyclosporine in combination. Transplant Proc 1998; 30: 1027-1028. (Pubitemid 28309466)
5. Takada M, Nadeau KC, Shaw GD, Marquette KA, Tilney NL,. The cytokine-adhesion molecule cascade in ischemia/reperfusion injury of the rat kidney. Inhibition by a soluble P-selectin ligand. J Clin Invest 1997; 99: 2682-2690. (Pubitemid 27259815)
6. Kupiec-Weglinski JW, Busuttil RW,. Ischemia and reperfusion injury in liver transplantation. Transplant Proc 2005; 37: 1653-1656. (Pubitemid 40790787)
7. HHS/HRSA/HSB/DOT. OPTN/SRTR Annual Report: Transplant Data 1998-2007. 2008.
8. Busuttil RW, Tanaka K,. The utility of marginal donors in liver transplantation. Liver Transpl 2003; 9: 651-663. (Pubitemid 36874450)
9. Tector AJ, Mangus RS, Chestovich P, et al,. Use of extended criteria livers decreases wait time for liver transplantation without adversely impacting posttransplant survival. Ann Surg 2006; 244: 439-450.
10. Mirza DF, Gunson BK, Da Silva RF, Mayer AD, Buckels JA, McMaster P,. Policies in Europe on "marginal quality" donor livers. Lancet 1994; 344: 1480-1483.
11. Amersi F, Farmer DG, Shaw GD, et al,. P-selectin glycoprotein ligand-1 (rPSGL-Ig)-mediated blockade of CD62 selectin molecules protects rat steatotic liver grafts from ischemia/reperfusion injury. Am J Transplant 2002; 2: 600-608. (Pubitemid 36306851)
12. Shaked A, Nunes FA, Olthoff KM, Lucey MR,. Assessment of liver function: Pre- and peritransplant evaluation. Clin Chem 1997; 43 (8 Pt 2): 1539-1545. (Pubitemid 27329813)
13. Khan AW, Fuller BJ, Shah SR, Davidson BR, Rolles K,. A prospective randomized trial of N-acetyl cysteine administration during cold preservation of the donor liver for transplantation. Ann Hepatol 2005; 4: 121-126.
14. Rosen HR, Martin P, Goss J, et al,. Significance of early aminotransferase elevation after liver transplantation. Transplantation 1998; 65: 68-72. (Pubitemid 28100433)
15. Basile J, Busuttil A, Sheiner PA, et al,. Correlation between von Willebrand factor levels and early graft function in clinical liver transplantation. Clin Transplant 1999; 13 (1 Pt 1): 25-31. (Pubitemid 29110385)
16. Deschenes M, Belle SH, Krom RA, Zetterman RK, Lake JR,. Early allograft dysfunction after liver transplantation: A definition and predictors of outcome. National Institute of Diabetes and Digestive and Kidney Diseases Liver Transplantation Database. Transplantation 1998; 66: 302-310.
17. Gaber AO, Mulgaonkar S, Kahan BD, et al,. rPSGL-Ig (rPSGL-Ig) for improvement of early renal allograft function: a double-blind, placebo-controlled, multi-center phase IIa study. Clin Transplant 2010, in press.
18. Feng S, Goodrich NP, Bragg-Gresham JL, et al,. Characteristics associated with liver graft failure: The concept of a donor risk index. Am J Transplant 2006; 6: 783-790. (Pubitemid 43345017)
19. Ascon M, Ascon DB, Liu M, et al,. Renal ischemia-reperfusion leads to long term infiltration of activated and effector-memory T lymphocytes. Kidney Int 2009; 75: 526-535.
20. Farmer DG, Shen XD, Amersi F, et al,. CD62 blockade with P-Selectin glycoprotein ligand-immunoglobulin fusion protein reduces ischemia-reperfusion injury after rat intestinal transplantation. Transplantation 2005; 79: 44-51. (Pubitemid 40139999)
21. Gasser M, Waaga-Gasser AM, Grimm MW, et al,. Selectin blockade plus therapy with low-dose sirolimus and cyclosporin a prevent brain death-induced renal allograft dysfunction. Am J Transplant 2005; 5 (4 Pt 1): 662-670. (Pubitemid 40461275)
22. Mertens P, Maes A, Nuyts J, et al,. Recombinant P-selectin glycoprotein ligand-immunoglobulin, a P-selectin antagonist, as an adjunct to thrombolysis in acute myocardial infarction. The P-Selectin Antagonist Limiting Myonecrosis (PSALM) trial. Am Heart J 2006; 152: 125.e1-125.e8.
23. Tanguay JF, Krucoff M, Gibbons R,. Efficacy of a novel P-selectin antagonist, rPSGL-Ig for reperfusion therapy in acute myocardial infarction: The RAPSODY Trial. J Am Coll Cardiol 2003: [Abstract 404A.
24. Cheadle C, Watkins T, Ehrlich E, et al,. Effects of anti-adhesive therapy on kidney biomarkers of ischemia reperfusion injury in human deceased donor kidney allografts. Clin Transplants, in press.
25. Liu Z, Xu W, Zhang X, Cui D, Liu B,. Expression of the CXC chemokine receptor 3 and its ligands in ischemia-reperfusion injury of liver in rats. Transplant Proc 2008; 40: 1300-1302. (Pubitemid 351853215)
26. Zhai Y, Shen XD, Gao F, et al,. CXCL10 regulates liver innate immune response against ischemia and reperfusion injury. Hepatology 2008; 47: 207-214. (Pubitemid 351171058)
27. Shen XD, Ke B, Zhai Y, et al,. Absence of toll-like receptor 4 (TLR4) signaling in the donor organ reduces ischemia and reperfusion injury in a murine liver transplantation model. Liver Transpl 2007; 13: 1435-1443. (Pubitemid 47629578)
28. Ke B, Shen XD, Tsuchihashi S, et al,. Viral interleukin-10 gene transfer prevents liver ischemia-reperfusion injury: Toll-like receptor-4 and heme oxygenase-1 signaling in innate and adaptive immunity. Hum Gene Ther 2007; 18: 355-366. (Pubitemid 46709347)
29. Buis CI, Van Der Steege G, Visser DS, et al,. Heme oxygenase-1 genotype of the donor is associated with graft survival after liver transplantation. Am J Transplant 2008; 8: 377-385.
30. Kotsch K, Ulrich F, Reutzel-Selke A, et al,. Methylprednisolone therapy in deceased donors reduces inflammation in the donor liver and improves outcome after liver transplantation: A prospective randomized controlled trial. Ann Surg 2008; 248: 1042-1050.
31. Baskin-Bey ES, Washburn K, Feng S, et al,. Clinical trial of the pan-caspase inhibitor, IDN-6556, in human liver preservation injury. Am J Transplant 2007; 7: 218-225. (Pubitemid 44952876)
32. Bogetti D, Sankary HN, Jarzembowski TM, et al,. Thymoglobulin induction protects liver allografts from ischemia/reperfusion injury. Clin Transplant 2005; 19: 507-511. (Pubitemid 40990661)
33. St Peter SD, Post DJ, Rodriguez-Davalos MI, Douglas DD, Moss AA, Mulligan DC,. Tacrolimus as a liver flush solution to ameliorate the effects of ischemia/reperfusion injury following liver transplantation. Liver Transplant 2003; 9: 144-149. (Pubitemid 36204565)
34. Lang JD Jr,., Teng X, Chumley P, et al,. Inhaled NO accelerates restoration of liver function in adults following orthotopic liver transplantation. J Clin Invest 2007; 117: 2583-2591. (Pubitemid 47494359)