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A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs Povetacicept (Primary)
  • Indications IgA nephropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms RAINIER
  • Sponsors Alpine Immune Sciences

Most Recent Events

  • 23 Jun 2025 According to Ono Pharmaceutical media release, If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the U.S.And Final analysis will occur at two years of treatment, with a primary endpoint of total eGFR slope through Week 104.
  • 05 May 2025 According to a Vertex Pharma media release, company announced that the enrollment of the interim analysis cohort has been completed.The interim analysis will be conducted once this cohort reaches 36 weeks of treatment, with the potential to file for Accelerated Approval in the U.S. in the first half of 2026
  • 14 Mar 2025 Planned End Date changed from 1 Sep 2028 to 30 Sep 2028.

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