CALT - Calliditas completes enrollment in late-stage Nefecon trial
Calliditas Therapeutics ([[CALT]]) has announced that all 360 patients have been enrolled for the global Phase 3 trial NefIgArd comprising Part A and Part B, evaluating the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN).Calliditas read out topline data from Part A of the trial, 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 of the trial 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.
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Calliditas completes enrollment in late-stage Nefecon trial