A european multicentre and open-label controlled randomized trial to evaluate the efficacy of sequential treatment with TAcrolimus-Rituximab versus steroids plus cyclophosphamide in patients with primary MEmbranous Nephropathy: The STARMEN study

Clinical Kidney Journal

Volumn 8, Issue 5, 2015, Pages 503-510

  Rojas Rivera, Jorge ^a,b   Fernández Juárez, Gema ^b,c   Ortiz, Alberto ^a,b   Hofstra, Julia ^d   Gesualdo, Loreto ^e   Tesar, Vladimir ^f   Wetzels, Jack ^d   Segarra, Alfons ^b,g   Egido, Jesus ^a   Praga, Manuel ^b,h  

^a UNIVERSIDAD AUTÓNOMA DE MADRID   (Spain)

^b Renal Research Network (REDINREN)   (Spain)

^c HOSPITAL UNIVERSITARIO FUNDACIÓN ALCORCÓN   (Spain)

^d RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^e Struttura Complessa di Nefrologia Dialisi e Trapianto Ospedaliero Universitaria   (Italy)

^f CHARLES UNIVERSITY   (Czech Republic)

^g HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^h HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

Author keywords

Biomarker; Immunosuppression; Membranous nephropathy; Nephrotic syndrome; Randomized controlled trial

Indexed keywords

CORTICOSTEROID; CYCLOPHOSPHAMIDE; METHYLPREDNISOLONE; PHOSPHOLIPASE A2 RECEPTOR; RITUXIMAB; TACROLIMUS;

ADULT; ANTIBODY BLOOD LEVEL; ARTICLE; CLINICAL PROTOCOL; CONTROLLED STUDY; CORTICOSTEROID THERAPY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; EUROPEAN; EVALUATION STUDY; HUMAN; MAJOR CLINICAL STUDY; MEMBRANOUS GLOMERULONEPHRITIS; MULTICENTER STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REMISSION; SINGLE DRUG DOSE; TREATMENT DURATION; TREATMENT RESPONSE;

EID: 84954067252     PISSN: 20488505     EISSN: 20488513     Source Type: Journal    
DOI: 10.1093/ckj/sfv075     Document Type: Article

References (37)

1. Haas M, Meehan SM, Karrison TG et al. Changing etiologies of unexplained adult nephrotic syndrome: a comparison of renal biopsy findings from 1976-1979 and 1995-1999. Am J Kidney Dis 1997;30:621-631
2. Schieppati A, Mosconi L, Perna A et al. Prognosis of untreated patients with idiopathic membranous nephropathy. N Eng J Med 1993;329:85-89
3. Polanco N, Gutierrez E, Covarsi A et al. Spontaneous remission of nephrotic syndrome in idiopathic membranous nephropathy. J Am Soc Nephrol 2010;21:697-704
4. Cattran DC, Pei Y, Greenwood CM et al. Validation of a predictive model of idiopathic membranous nephropathy: its clinical and research implications. Kidney Int 1997;51:901-907
5. Branten AJ, du Buf-Vereijken PW, Klasen IS et al. Urinary excretion of β2-microglobulin and IgG predicts prognosis in idiopathic membranous nephropathy: a validation study. J Am Soc Nephrol 2005;16:169-174
6. Cattran D. Management of membranous nephropathy: when and what for treatment. J Am Soc Nephrol 2005;16:1188-1194
7. 2 receptor as target antigen in idiopathic membranous nephropathy. N Engl J Med 2009;361:11-21
8. 2 antibody in membranous nephropathy. J Am Soc Nephrol 2011;22:1137-1143
9. 2 receptor in glomeruli correlates with serum receptor antibodies in primary membranous nephropathy. Kidney Int 2012;82:797-804
10. 2 receptor antibody titer and subclass in idiopathic membranous nephropathy. J Am Soc Nephrol 2012;23:1735-1743
11. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerulonephritis Work Group. KDIGO clinical practice guideline for glomerulonephritis. Kidney Int Suppl 2012;2:139-274
12. Hofstra J, Wetzels JFM. Alkylating agents in membranous nephropathy: efficacy proven beyond doubt. Nephrol Dial Transplant 2010;25:1760-1766
13. Ponticelli C, Altieri P, Scolari F et al. A randomized study comparing methylprednisolone plus chlorambucil versus methylprednisolone plus cyclophosphamide in idiopathic membranous nephropathy. J Am Soc Nephrol 1998;9:444-450
14. Ponticelli C, Zucchelli P, Passerini P et al. A 10-year follow-up of a randomized study with methylprednisolone and chlorambucil in membranous nephropathy. Kidney Int 1995;48:1600-1604
15. Jha V, Ganguli A, Saha TK et al. A randomized, controlled trial of steroids and cyclophosphamide in adults with nephrotic syndrome caused by idiopathic membranous nephropathy. J Am Soc Nephrol 2007;18:1899-1904
16. Praga M, Barrio V, Fernandez-Juarez G et al. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial. Kidney Int 2007;71:924-930
17. Goumenos DS, Katopodis KP, Passadakis P et al. Corticosteroids and cyclosporine A in idiopathic membranous nephropathy: higher remission rates of nephrotic syndrome and less adverse reactions than after traditional treatment with cytotoxic drugs. Am J Nephrol 2007;27:226-231
18. Cattran DC, Appel GB, Hebert LA et al. Cyclosporine in patients with steroid-resistant membranous nephropathy: a randomized trial. Kidney Int 2001;59:1484-1490
19. Caro J, Gutiérrez-Solis E, Rojas-Rivera J et al. Predictors of response and relapse in patients with idiopathic membranous nephropathy treated with tacrolimus. Nephrol Dial Transplant 2015;30:467-474
20. Chen M, Li H, Li XY et al. Tacrolimus combined with corticosteroids in treatment of nephrotic idiopathic membranous nephropathy: a multicenter randomized controlled trial. Am J Med Sci 2010;339:233-238
21. Howman A, Chapman TL, Langdon MM et al. Immunosuppression for progressive membranous nephropathy: a UK randomised controlled trial. Lancet 2013;381:744-751
22. Looney RJ, Anolik JH, Campbell D et al. B cell depletion as a novel treatment for systemic lupus erythematosus: a phase I/II dose-escalation trial of rituximab. Arthritis Rheum 2004;50:2580-2589
23. Ruggenenti P, Chiurchiu C, Brusegan V et al. Rituximab in idiopathic membranous nephropathy: a one-year prospective study. J Am Soc Nephrol 2003;14:1851-1857
24. Fervenza F, Abraham RS, Erikson SB et al. Rituximab therapy in idiopathic membranous nephropathy: a 2-year study. Clin J Am Soc Nephrol 2010;5:2188-2198
25. Bomback AS, Derebail VK, McGregor JG et al. Rituximab therapy for membranous nephropathy: a systematic review. Clin J Am Soc Nephrol 2009;4:734-744
26. Waldman M, Austin HA III. Controversies in the treatment of idiopathic membranous nephropathy. Nat Rev Nephrol 2009;5:469-479
27. Segarra A, Praga M, Ramos N et al. Successful treatment of membranous glomerulonephritis with rituximab in calcineurin inhibitor-dependent patients. Clin J Am Soc Nephrol 2009;4:1083-1088
28. Fervenza FC, Cosio FG, Erickson SB et al. Rituximab treatment of idiopathic membranous. Kidney Int 2008;73:117-125
29. Goto S, Goto H, Tanoshima R et al. Serumsickness with an elevated level of human anti-chimeric antibody following treatment with rituximab in a child with chronic immune thrombocytopenic purpura. Int J Hematol 2009;89:305-309
30. Sequential therapy with tacrolimus and rituximab in primary membranous nephropathy (STARMEN). Verified November 2014. Available in: http://clinicaltrials.gov/ct2/show/NCT01955187
31. 2R antibodies with outcomes after immunosuppressive therapy in idiopathic membranous nephropathy. Clin J Am Soc Nephrol 2014;9:1386-1392
32. Murtas C, Bruschi M, Candiano G et al. Coexistence of different circulating anti-podocyte antibodies in membranous nephropathy. Clin J Am Soc 2012;7:1394-1400
33. Tomas NM, Beck LH, Meyer-Schwesinger C et al. Thrombospondin type-1 domain-containing 7A in idiopathic membranous nephropathy. N Engl J Med 2014;371:2277-2287
34. Friedman LM, Furberg CD, De Mets DL. Fundamentals of Clinical Trials, 4th ed. New York, USA: Springer, 2010
35. Hulley SB, Cummings SM, Browner WS et al. Designing Clinical Research, 3rd ed. Philadelphia, USA: Lippincott Williams and Wilkins, 2007
36. Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. Florida, USA: Taylor & Francis group, LLC, 2003
37. Lachin JM. Introduction to simple size determination and power analysis for clinical trials. Control Clin Trials 1981;2:93-113