On January 21, 2021 Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX – CALTX; NASDAQ – CALT) reported that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN) (Press release, Calliditas Therapeutics, JAN 21, 2021, View Source [SID1234576684]).
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The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon. Calliditas read out positive topline data from Part A of the trial on 8 November 2020, announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR. It also showed that Nefecon was generally well-tolerated.
Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. The 360-patient population of the Phase 3 trial includes the further 160 patients enrolled in addition to the 200 patients from Part A.
"To have fully enrolled our Phase 3 pivotal trial is a great milestone, even more so as we achieved this during the pandemic, which reflects the commitment of investigators and patients, as well as that of our experienced clinical team." said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.
The information was sent for publication, through the agency of the contact persons set out above, on January 21, 2021 at 08:30 a.m. CET.