DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS.
Publication/Presentation Date
11-1-2018
Abstract
BACKGROUND: We evaluated and compared the effects of sparsentan, a dual endothelin type A (ET
METHODS: In this phase 2, randomized, double-blind, active-control Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients with Focal Segmental Glomerulosclerosis (FSGS): A Randomized, Double-blind, Active-Control, Dose-Escalation Study (DUET), patients aged 8-75 years with biopsy-proven FSGS, eGFR>30 ml/min per 1.73 m
RESULTS: Of 109 patients randomized, 96 received study drugs and had baseline and week 8 UP/C measurements. Sparsentan-treated patients had greater reductions in UP/C than irbesartan-treated patients did when all doses (45% versus 19%;
CONCLUSIONS: Patients with FSGS achieved significantly greater reductions in proteinuria after 8 weeks of sparsentan versus irbesartan. Sparsentan was safe and well tolerated.
Volume
29
Issue
11
First Page
2745
Last Page
2754
ISSN
1533-3450
Published In/Presented At
Trachtman, H., Nelson, P., Adler, S., Campbell, K. N., Chaudhuri, A., Derebail, V. K., Gambaro, G., Gesualdo, L., Gipson, D. S., Hogan, J., Lieberman, K., Marder, B., Meyers, K. E., Mustafa, E., Radhakrishnan, J., Srivastava, T., Stepanians, M., Tesar, V., Zhdanova, O., Komers, R., … DUET Study Group (2018). DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS. Journal of the American Society of Nephrology : JASN, 29(11), 2745–2754. https://doi.org/10.1681/ASN.2018010091
Disciplines
Medicine and Health Sciences
PubMedID
30361325
Department(s)
Department of Medicine
Document Type
Article