Calliditas’ Nefecon Meets its Primary Endpoint in P-III Trial (NefIgArd) for the Treatment of IgA Nephropathy
- The P-III trial (NefIgArd) evaluating Tarpeyo (16mg, qd) vs PBO in a ratio (1:1) in 364 patients as an addition to optimized RAS inhibitor therapy. Part A of the study incl. a 9mos. blinded treatment period & 3mos. follow-up period while Part B incl. a 12mos. observational period
- The trial met its 1EPs & showed a benefit in eGFR over 2yr. period of 9mos. of treatment & 15mos. of follow-up, 2yr. total slope analyses reflected a sustained treatment benefit, UPCR reductions reflected a treatment effect during the 15mos. the follow-up period. The therapy was well-tolerated & safety profile was consistent with Part A of the trial
- Nefecon was marketed under the brand name Tarpeyo in the US & by STADA Arzneimittel AG in the EEA, Switzerland & the UK under Kinpeygo
Ref: Prnewswire | Image: Calliditas
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