دورية أكاديمية
DUET: A phase 2 study evaluating the efficacy and safety of sparsentan in patients with FSGS
| العنوان: | DUET: A phase 2 study evaluating the efficacy and safety of sparsentan in patients with FSGS |
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| المؤلفون: | 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, Esposito C. |
| المساهمون: | 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, Esposito, C. |
| سنة النشر: | 2018 |
| المجموعة: | IRIS UNIPV (Università degli studi di Pavia) |
| مصطلحات موضوعية: | angiotensin II, endothelin, focal segmental glomerulosclerosi, proteinuria, sparsentan, Adolescent, Adult, Aged, Angiotensin II Type 1 Receptor Blocker, Child, Creatinine, Dose-Response Relationship, Drug, Double-Blind Method, Endothelin A Receptor Antagonist, Female, Glomerulosclerosis, Focal Segmental, Human, Irbesartan, Male, Middle Aged, Spiro Compound, Sulfonamide, Young Adult |
| الوصف: | Background: We evaluated and compared the effects of sparsentan, a dual endothelin type A (ETA) and angiotensin II type 1 receptor antagonist, with those of the angiotensin II type 1 receptor antagonist irbesartan in patients with primary FSGS. 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 yearswith biopsy-proven FSGS, eGFR>30ml/min per 1.73m2, and urinary protein-to-creatinine ratio (UP/C)≥1.0 g/g received sparsentan (200, 400, or 800 mg/d) or irbesartan (300mg/d) for 8 weeks, followed by open-label sparsentan only. End points atweek 8 were reduction from baseline inUP/C(primary) and proportion of patients achieving FSGS partial remission end point (FPRE) (UP/C:≤1.5 g/g and>40%reduction [secondary]). 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 didwhen all doses (45%versus 19%; P=0.006) or the 400 and 800mg doses (47%versus 19%; P=0.01) were pooled for analysis. The FSGS partial remission end point was achieved in 28% of sparsentan-treated and 9% of irbesartan-treated patients (P=0.04). After 8 weeks of treatment, BP was reduced with sparsentan but not irbesartan, and eGFR was stable with both treatments. Overall, the incidence of adverse events was similar between groups. Hypotension and edema were more common among sparsentan-treated patients but did not result in study withdrawals. Conclusions: Patients with FSGS achieved significantly greater reductions in proteinuria after 8 weeks of sparsentan versus irbesartan. Sparsentan was safe and well tolerated. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | ELETTRONICO |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/30361325; info:eu-repo/semantics/altIdentifier/wos/WOS:000449144200016; volume:29; issue:11; firstpage:2745; lastpage:2754; numberofpages:10; journal:JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY; http://hdl.handle.net/11571/1323326Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85055841083; https://jasn.asnjournals.org/content/jnephrol/29/11/2745.full.pdfTest |
| DOI: | 10.1681/ASN.2018010091 |
| الإتاحة: | https://doi.org/10.1681/ASN.2018010091Test http://hdl.handle.net/11571/1323326Test https://jasn.asnjournals.org/content/jnephrol/29/11/2745.full.pdfTest |
| رقم الانضمام: | edsbas.8E21BDE7 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1681/ASN.2018010091 |
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