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A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)

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Trial Profile

A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2024

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At a glance

  • Drugs Rilparencel (Primary)
  • Indications Kidney disorders; Renal failure
  • Focus Registrational; Therapeutic Use
  • Acronyms proact 2
  • Sponsors ProKidney

    • Most Recent Events

    • 23 Sep 2024 According to ClinicalTrials.gov, this trial is withdrawn as Rilparencel is eligible for initial FDA/ RMAT approval pathway upon successful completion Phase3 REGEN006 (PROACT1) trial. Discontinued Phase3 REGEN016 (PROACT2) focused on enrollment outside the US and is not required for initial US registration.
    • 23 Sep 2024 Status changed from recruiting to discontinued.
    • 26 Jul 2024 Status changed from not yet recruiting to recruiting.

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