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Efficacy and Safety of Sparsentan Versus Irbesartan
in Patients With IgA Nephropathy (PROTECT):
2-year Results From a Randomised,
Active-Controlled, Phase 3 Trial

Journal article
Published on November 3, 2023

Topics: Nephrology IgAN Sparsentan PROTECT Phase 3 Journal article

Contributors:
Rovin BH, Barratt J, Heerspink HJL et al.
Name of Journal:
The Lancet


View Publication
DOI:
10.1016/S0140-6736(23)02302-4
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Home » Publications » PROTECT Phase 3 Trial

About this study

Summary

Background
IgA nephropathy is a rare kidney disease. It can lead to progressive kidney function decline and kidney failure within 10 to 20 years of diagnosis1,2
Endothelin-1 (ET-1) and angiotensin II (Ang II) are two critical peptides that act in tandem and are responsible for the progression of IgA nephropathy over time3,4
Sparsentan is an FDA approved (under accelerated approval)
non-immunosuppressive, single-molecule, Dual Endothelin Angiotensin Receptor Antagonist (DEARA) indicated to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g5-7
Downloadable Resource
Nephrology
Urine sample

Learn more about the two-year findings from PROTECT

Aim

The PROTECT study evaluates long-term efficacy and safety of sparsentan versus irbesartan in IgA nephropathy6

PROTECT: A large, international, randomized,
double-blind, active controlled Phase 3 trial

Diagram illustration of the PROTECT study examining sparsentan versus irbesartan.
Key findings
Urine sample container

Sparsentan met its primary endpoint showing superior reductions in proteinuria from baseline to Week 36 versus irbesartan. This reduction was sustained over 2 years6,8

Pair of kidneys

The absolute LS mean change in eGFR from baseline to Week 110 was smaller with sparsentan vs. irbesartan, demonstrating a greater preservation of kidney function with sparsentan6

Scales of justice

The safety profile of sparsentan is comparable with that of irbesartan6

Hands holding a first aid sign

The most common TEAEs were COVID-19, hyperkalemia, peripheral edema, dizziness, headache and hypotension6

Swollen foot, damaged liver, and a heart

There were no instances of drug-induced liver injury or discontinuations due to heart failure or edema6

Conclusions

Sparsentan demonstrated6:

Superior reductions in proteinuria
Better preservation of kidney function that accrued year on year
Prolonged kidney survival
A comparable safety profile with irbesartan
Group of people

Related Content

Publication IgAN

Implementing the Kidney Health Initiative Surrogate Efficacy Endpoint in Patients With IgA Nephropathy (the PROTECT Trial)

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Publication IgAN

IgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study

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Publication IgAN

Sparsentan in Patients With IgA Nephropathy: A Prespecified Interim Analysis From a Randomised, Double-Blind, Active-Controlled Clinical Trial

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See more
Footnotes

*Participants were enrolled between December 2018 and May 2021.

Ang II, angiotensin II; AT1R, angiotensin II subtype 1 receptor; COVID-19, coronavirus disease 2019; DEARA, Dual Endothelin Angiotensin Receptor Antagonist; eGFR, estimated glomerular filtration rate; ET-1, endothelin 1; ETAR, endothelin type A receptor; FDA, Food and Drug Administration; IgA, immunoglobulin A; LS, least square; UPCR, urine protein-creatinine ratio.

  1. Kwon CS et al. J Health Econ Outcomes Res. 2021;8(2):36-45.
  2. Pitcher D et al. Clin J Am Soc Nephrol. 2023;18(6):727-738.
  3. Martínez-Díaz I et al. Int J Mol Sci. 2023;24(4):3427.
  4. Komers R, Plotkin H. Am J Physiol Regul Integr Comp Physiol. 2016;310(10):R877-884.
  5. FILSPARI™ (sparsentan) Prescribing Information. San Diego, CA: Travere Therapeutics, Inc. 2/2023
  6. Rovin BH et al. Lancet. 2023;402(10417):2077-2090.
  7. Food and Drug Administration. Accelerated Approval Program. Accessed March 15, 2023. https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
  8. Heerspink HJL et al. Lancet. 2023;401(10388):1584-1594.

MA-SP-24-0049 | June 2024