A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis

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Presentation transcript:

A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis Flavio Vincenti, Fernando C. Fervenza, Kirk N. Campbell, Montserrat Diaz, Loreto Gesualdo, Peter Nelson, Manuel Praga, Jai Radhakrishnan, Lorenz Sellin, Ajay Singh, Denyse Thornley-Brown, Francisco Veríssimo Veronese, Beverly Accomando, Sara Engstrand, Steven Ledbetter, Julie Lin, John Neylan, James Tumlin Kidney International Reports Volume 2, Issue 5, Pages 800-810 (September 2017) DOI: 10.1016/j.ekir.2017.03.011 Copyright © 2017 International Society of Nephrology Terms and Conditions

Figure 1 Consolidated Standards of Reporting Trials (CONSORT) diagram. Kidney International Reports 2017 2, 800-810DOI: (10.1016/j.ekir.2017.03.011) Copyright © 2017 International Society of Nephrology Terms and Conditions

Figure 2 (a) Estimated mean percent change in urinary protein/creatinine ratio (Up/c) from baseline to day 112/visit 6 by treatment assignment. (b) Mean (± SE) percent change from baseline in estimated glomerular filtration rate (eGFR) over time by treatment assignment. Kidney International Reports 2017 2, 800-810DOI: (10.1016/j.ekir.2017.03.011) Copyright © 2017 International Society of Nephrology Terms and Conditions

Figure S1 Focal segmental glomerulosclerosis (FSGS) patients assigned to 1 mg/kg (n = 14). Kidney International Reports 2017 2, 800-810DOI: (10.1016/j.ekir.2017.03.011) Copyright © 2017 International Society of Nephrology Terms and Conditions

Figure S2 Focal segmental glomerulosclerosis (FSGS) patients assigned to placebo (n = 10). Kidney International Reports 2017 2, 800-810DOI: (10.1016/j.ekir.2017.03.011) Copyright © 2017 International Society of Nephrology Terms and Conditions

Figure S3 Focal segmental glomerulosclerosis (FSGS) patients assigned to 1 mg/kg with > 1 partial remission event (n = 6). Kidney International Reports 2017 2, 800-810DOI: (10.1016/j.ekir.2017.03.011) Copyright © 2017 International Society of Nephrology Terms and Conditions

Figure S4 Focal segmental glomerulosclerosis (FSGS) patients assigned to 4 mg/kg (n = 12; 3 treated with other immunosuppressant medications). Kidney International Reports 2017 2, 800-810DOI: (10.1016/j.ekir.2017.03.011) Copyright © 2017 International Society of Nephrology Terms and Conditions

Figure S5 Postinfusion fresolimumab serum concentrations (mean ± SE). Kidney International Reports 2017 2, 800-810DOI: (10.1016/j.ekir.2017.03.011) Copyright © 2017 International Society of Nephrology Terms and Conditions