Re: Hepalink IPO Document and what it says about RVX
in response to
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posted on
Jan 27, 2020 01:25PM
Cabel - The duration of a Ph3 for KD will be determined by the endpoint. Possibilities include eGFR again (an estimate of true GFR based on serum creatinine), true GFR (measured by infusing an exogenous filtration marker and measuring it in the blood and urine) or a clinical endpoint. I am not a kidney expert, but my guess is it might be true GFR as clinical endpoints would mean a very big trial.
If eGFR was significantly increased in BETonMACE and true GFR is to be the endpoint, the size and duration of a Ph3 will be determined by the magnitude and time course of the improvement in eGFR in BETonMACE. Let’s hope those data will be presented soon.
The inclusion of 11% of the BETonMACE patients in a new Ph3 is interesting as it complicates the trial design somewhat and is presumably aimed at expediting the outcome. This would fit with a BT status for CKD.
All imo. Time will tell!