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Study Summary:

The primary objective of this study is to evaluate the proportion of subjects achieving proteinuria ≤1g/24hr, OR a reduction in proteinuria of ≥50% from baseline following 104 weeks of therapy with blisibimod compared with placebo.S

For latest updates please go to clinicaltrials.gov

 

Status:

To be initiated in Q2 2013

 

Anthera Posters & Publications:

 

Renal Publications:

Curtis JR, Westfall AO, Allison J, Bijlsma JW, Freeman A, George V, et al. Population-based assessment of adverse events associated with long-term glucocorticoid use. Arthritis Rheum 2006;55(3):420-426.
doi: 10.1002/art.21984

Dooley M, Houssiau F, Aranow C, D'Cruz D, Askanase A, Roth D, Zhong Z, Cooper S, Freimuth W, Ginzler E. Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE. Lupus. 2013;22(1):63-72. Donadio JV and Grande JP. IgA nephropathy. N Engl J Med 2002;347(10): 738-48. Floege J and Eitner F. Current therapy for IgA nephropathy. J Am Soc Nephrol 2011;22:1785-94.
doi: 10.1177/0961203312465781.

Kim SJ, Koo HM, Lim BJ, Oh HJ, Yoo DE, Shin DH, Lee MJ, Doh FM, Park JT, Yoo TH, Kang SW, Choi KH, Jeong HJ, Han SH. Decreased circulating C3 levels and mesangial C3 deposition predict renal outcome in patients with IgA nephropathy. PLoS One. 2012;7(7).
doi: 10.1371/journal.pone.0040495.

Lv J, Zhang H, Chen Y, Li G, Jiang L, Singh AK, Wang H. Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. Am J Kidney Dis 2009;53(1):26-32.
doi: 10.1053/j.ajkd.2008.07.029.

Mackay F, Schneider P, Rennert P, Browning J. BAFF and APRIL: A tutorial on B cell survival. Annu Rev Immunol 2003;21:231-64.
doi: 10.1146/annurev.immunol.21.120601.141152

McCarthy DD, Kujawa J, Wilson C, Papandile A, Poreci U, Porfilio EA, et al. Mice overexpressing BAFF develop a commensal flora-dependent, IgA-associated nephropathy. J Clin Invest 2011;121(10):3991-4002.
doi: 10.1172/JCI45563.

McGrogan A, Franssen CF, de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant 2011; 26(2):414-30.
doi: 10.1093/ndt/gfq665

Pozzi C, Andrulli S, Del Vecchio L, Melis P, Fogazzi GB, Altieri P, et al. Corticosteroid effectiveness in IgA nephropathy: Long-term results of a randomized, controlled trial. J Am Soc Nephrol 2004;15:157-163.
doi: 10.1097/01.ASN.0000103869.08096

Roberts ISD, Cook HT, Troyanov S, Alpers CE, Amore A, Barratt J, et al. The Oxford classification of IgA nephropathy: pathology definitions, correlations, and reproducibility. Kidney Int 2009;76:546-56.
doi: 10.1038/ki.2009.168

Reich HN, Troyanov S, Scholey JW, Cattran DC; Toronto Glomerulonephritis Registry. Remission of proteinuria improves prognosis in IgA nephropathy. J Am Soc Nephrol 2007 Dec;18(12):3177-83.
doi: 10.1681/ASN.2007050526

Rosselli JL, Thacker SM, Karpinski JP, Petkewicz KA. Treatment of IgA nephropathy: An update. Ann Pharmacother 2011;45:1284-96.
doi

Sampson H, Munoz-Furlong A, Campbell R, Adkinson NF, Bock SA, Branum A, et al. Second symposium on the definition and management of anaphylaxis: Summary report – Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol 2006;117:391-7.
doi:10.1016/j.jaci.2005.12.1303

Stohl W, Hiepe F, Thomas M, Scheinberg M, Clarke A, Aranow C, Jimenez R, Wellborne F, Abud-Mendoza C, Hough D, Pineda L, Migone TS, Freimuth W, Chatham W. Belimumab, a BLyS-Specific Inhibitor, Significantly Reduced Autoantibodies, Normalized Low Complement, and Reduced Selected B-Cell Populations in Patients With Seropositive Systemic Lupus Erythematosus (SLE): The Phase 3 BLISS Studies. ACR Annual Meeting 2010.
doi: 10.1002/art.28912

Sugiura H, Takei Ta, Itabashi M, Tsukada M, Moriyama T, Kojima C, et al. Effect of single-dose rituximab on primary glomerular diseases. Nephron Clin Pract 2011;117:c98-105.
doi: 10.1159/000319656.

Suzuki H, Kiryluk K, Novak J, Moldoveanu Z, Herr AB, Refrow MB, et al. The pathophysiology of IgA nephropathy. J Am Soc Nephrol. 2011;22:1795-1803.
doi: 10.1681/ASN.2011050464

Tumlin JA, Madaio MP, Hennigar R. Idiopathic IgA nephropathy: Pathogenesis, histopathology, and therapeutic options. Clin J Am Soc Nephrol 2004;2:1054-61.
doi: 10.2215/​CJN.04351206

Yuling H, Ruijing X, Xiang J, Yanping J, Lang C, Li L, et al. CD19+CD5+ B cells in primary IgA nephropathy. J Am Soc Nephrol 2008;19:2130-39.
doi: 10.1681/ASN.2007121303

 

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