Expert Interview
A look at the PROTECT study data for Sparsentan in patients with IgA nephropathy and the current standard of care
Ticker(s): TVTXThis expert is a MD/PhD who specializes in kidney disease and treats patients for IgA Nephropathy. They are involved in research within the Nephrology space with dozens of publications.
Can you please describe your clinical practice?
Added By: sara_adminWhat is your current standard of care for your patients with IgA Nephropathy?
Added By: sara_adminWhat is Sparsentan's potential in kidney disease with a mechanism of action as a dual blocker of endothelin receptor type A and angiotensin II receptor type 1?
Do you typically use irbesartan and is this a good comparator to use as they are using for PROTECT and in their FSGS trials?
Thoughts on the clinical efficacy shown so far. In PROTECT, at 36 weeks, an interim analysis of Proteinuria showed Sparsentan reduced UP/C from baseline by 49.8% vs. 15.1% with Irbesartan. How important is this result for IgAN?
Added By: user1ae2bf5fCan you talk about igA Nephropathy and how it affects patients?
What are the current treatment options and how do you manage patients with
this disease?
Please discuss the mechanism of action of Sparsentan as a dual endothelin receptor type 1 and angiotensin I receptor type 1 antagonist and now this might impact kidney disease and specifically IgA ?
Please explain the importance of proteinuria and a reduction of proteinuria as it relates to the disease progression.
Please discuss the PROTECT trial design - specifically the use of irbesartan as a comparator. Is this the relevant comparison to make and something commonly used in IgAN patients?
Do you subscribe to the hypothesis that reduction in proteinuria will be predictive of the eGFR slope and then translate to benefit in the disease? is this well supported?
In PROTECT, Sparsentan treatment resulted in 49.8% reduction in Proteinuria at 36 weeks compared to 15 1% reduction with sparsentan. What is your impression?
Do you subscribe to the hypothesis that reduction in proteinuria will be predictive of the eGFR slope and then translate to benefit in the disease? is this well supported?
How confident are you in this translating to eGFR benefit at 110 weeks?
Are you familiar with the DUET study, the phase 2 trial of Sparsentan in FSGS, and it so how comfortable are you with the safety profile of this drug for FSGS, or IgAN? They claim there was no new safety signal in PROTECT
With Sparsentan now under FDA review for an accelerated approval for IgAN based on the proteinuria readout, do you think it should receive approval?
Thoughts on the recently approved Tarpeyo. Any thoughts on Atrasentan and how it might compare with sparsentan? Anything else you are excited about in the space?
In FSGS, the phase 3 Duplex study has now had its interim proteinuria readout and showed 42% reduction in proteinuria vs. 26% with irbesartan. Along the lines of the prior questions regarding gAN, would you want to see this approved for FSGS with accelerated approval based on this readout and what you have seen on 84 weeks eGFR data from the phase 2 study, and if approved would you be excited to use the drug in FSGS patients?
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