Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Summary

To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

Timeline

Start

2018-04-17

Primary completion

2023-03-20

Completion

2026-03-19

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (other test); Sparsentan vs Irbesartan; p = 0.7491; Slope difference 0.3 (95% CI -1.74 to 2.41); Mixed Models Analysis reads as mixed primary results NCT03493685 ↗

registry analysis (other test); Sparsentan vs Irbesartan; p = 0.0094; Risk Difference (RD) 16.00 (95% CI 3.96 to 28.04); Mixed Models Analysis reads as mixed primary results NCT03493685 ↗

release “the pivotal Phase 3 DUPLEX Study evaluating sparsentan in focal segmental glomerulosclerosis (FSGS) did not achieve the primary efficacy eGFR slope endpoint” reads as missed primary endpoint ligand.com ↗

Publications

• Yee J, Gong W, Inrig J, Rheault MN, Gruber AJ, Bedard PW, Komers R, Trachtman H. Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated FSGS Enrolled in the DUPLEX Trial. Clin J Am Soc Nephrol. 2026 Apr 1;21(4):605-614. doi: 10.2215/CJN.0000000948. Epub 2025 Dec 23.
• Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2026 Jan 1;37(1):172-179. doi: 10.1681/ASN.0000000897. Epub 2025 Sep 12.
• Liu ID, Willis NS, Craig JC, Hodson EM. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2025 May 8;5(5):CD003594. doi: 10.1002/14651858.CD003594.pub7.
• Rheault MN, Alpers CE, Barratt J, Bieler S, Canetta P, Chae DW, Coppock G, Diva U, Gesualdo L, Heerspink HJL, Inrig JK, Kirsztajn GM, Kohan D, Komers R, Kooienga LA, Lieberman K, Mercer A, Noronha IL, Perkovic V, Radhakrishnan J, Rote W, Rovin B, Tesar V, Trimarchi H, Tumlin J, Wong MG, Trachtman H; DUPRO Steering Committee and DUPLEX Investigators. Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis. N Engl J Med. 2023 Dec 28;389(26):2436-2445. doi: 10.1056/NEJMoa2308550. Epub 2023 Nov 3.
• Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.
• Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Irbesartan	Small molecule	300 mg	Oral
Subject	Sparsentan	Small molecule	800 mg	Oral

Indications