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Swapnil Hiremath :renal: MD

Things getting weird with (who would have thunk!)

Remember bard is the nrf-2 activator and has been reported to *increase* GFR. This molecule bombed with the Ph 3 BEACON trial where it caused *more* HF and MACE nejm.org/doi/full/10.1056/nejm
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Figure 2. Kaplan–Meier Plots of the Time to the First Event of the Discrete Secondary Outcomes. Panel A shows the time to the first event of heart failure, defined as death due to heart failure or hospitalization for heart failure, among patients in the bardoxolone methyl group and those in the placebo group. Panel B shows the time to the first event of the secondary composite outcome (nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death from cardiovascular causes) in the two study groups. The first event was nonfatal myocardial infarction in 17 patients in the bardoxolone methyl group and 11 in the placebo group, nonfatal stroke in 12 patients in the bardoxolone methyl group and 8 in the placebo group, hospitalization for heart failure in 91 patients in the bardoxolone methyl group and 54 in the placebo group, and death from cardiovascular causes in 19 patients in the bardoxolone methyl group and 13 in the placebo group.
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Swapnil Hiremath :renal: MD

The concern for us was that the effect on GFR was an epiphenomena or an artifact or something else worse (after all RASi and flozins acutely reduce GFr but have better long term effect)
The TSUBAKI study suggested there was nothing to fear and it actually did increase GFR measured by inulin clearance

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Figure 2 Change from baseline in glomerular filtration rate (GFR) assessed by inulin clearance (interim per-protocol set). Data are least-squares mean (LSM) (95% confidence interval). P value indicates the difference between the LSM using the analysis of covariance model with treatment as a factor, and baseline values of GFR and log-transformed albumin/creatinine ratio as covariates,
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Swapnil Hiremath :renal: MD

This was followed by another Japanese RCT AYAME

Design and baseline data here academic.oup.com/ndt/article/3
this trial enrolled ~ 1000 peeps with GFR ~ 37 and ACR 350

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graphical abstract of AYAME trial
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Swapnil Hiremath :renal: MD

today we find out that the RCT results are mixed - and the company has halted further development of molecule

See press release PDF kyowakirin.com/media_center/ne

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Patients administered RTA 402 showed statistically significant improvement for “Time to onset a ≥ 30% decrease in eGFR from baseline or ESRD” and “Time to onset a ≥ 40% decrease in eGFR from baseline or ESRD”, thereby meeting the primary and key secondary endpoints. On the other hand, no difference in “Time to onset ESRD” between the two groups was observed. No significant safety issues were observed in the patients administered RTA 402.
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Swapnil Hiremath :renal: MD

As an aside, bardoxolone is a derivative of the indian 'tulsi' or holy basil

Tsubaki = Japanese camellia

Ayame = another Japanese iris

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Tulsi
Ayame
Tsubaki
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Swapnil Hiremath :renal: MD

@Rheault_m

And another one - the last FDA ruling was quite ….frank, and forthright. 13-0 ruling against approval

fda.gov/media/155275/download

Via @DrJMLuther

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Cristina Popa

@hswapnil this is Romanian basil(ic). As for the basil, don't promote it too much, we might soon treat basil intoxications 😅

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