drugset / Trial / NCT03762850
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).
Timeline
- Start
- 2018-12-11
- Primary completion
- 2023-08-07
- Completion
- 2026-07
Outcome
Met primary endpoint
registry analysis (other test); Sparsentan vs Irbesartan; p <0.0001; Geometric Mean Ratio 0.59 (95% CI 0.51 to 0.69); Mixed Models Analysis NCT03762850 ↗
release “The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance” ligand.com ↗
release “In August 2021, Travere announced the PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance.” ligand.com ↗
Publications
- Heerspink HJL, Rovin BH, Komers R, Hendry B, Mercer A, Preciado P, Murphy E, Tesar V. Association between Complete Proteinuria Remission and Kidney Function in the Phase 3 PROTECT Trial of Sparsentan in IgA Nephropathy. Clin J Am Soc Nephrol. 2026 Apr 1;21(4):578-592. doi: 10.2215/CJN.0000000961. Epub 2025 Dec 22.
- Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
- Rovin BH, Barratt J, Heerspink HJL, Alpers CE, Bieler S, Chae DW, Diva UA, Floege J, Gesualdo L, Inrig JK, Kohan DE, Komers R, Kooienga LA, Lafayette R, Maes B, Malecki R, Mercer A, Noronha IL, Oh SW, Peh CA, Praga M, Preciado P, Radhakrishnan J, Rheault MN, Rote WE, Tang SCW, Tesar V, Trachtman H, Trimarchi H, Tumlin JA, Wong MG, Perkovic V; DUPRO steering committee and PROTECT Investigators. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023 Dec 2;402(10417):2077-2090. doi: 10.1016/S0140-6736(23)02302-4. 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.
- Heerspink HJL, Radhakrishnan J, Alpers CE, Barratt J, Bieler S, Diva U, Inrig J, Komers R, Mercer A, Noronha IL, Rheault MN, Rote W, Rovin B, Trachtman H, Trimarchi H, Wong MG, Perkovic V; PROTECT Investigators. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023 May 13;401(10388):1584-1594. doi: 10.1016/S0140-6736(23)00569-X. Epub 2023 Apr 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 5 mg | Oral |
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Comparator | Irbesartan | Small molecule | 300 mg | Oral |
| Subject | Sparsentan | Small molecule | 400 mg | Oral |