A phase III study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS)

Trial Profile

A phase III study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS)

Planning
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Sparsentan (Primary)
  • Indications Focal segmental glomerulosclerosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Retrophin
  • Most Recent Events

    • 09 Aug 2017 According to a Retrophin media release, protocol design for this trial is complete and preparation for submission of the protocol to the US FDA is underway
    • 06 Mar 2017 New trial record
    • 01 Mar 2017 According to a Retrophin media release, the trial will include an interim analysis of proteinuria as a surrogate endpoint to serve as the basis for an NDA filing for Subpart H accelerated approval of sparsentan. The confirmatory endpoint of the study will subsequently compare changes from baseline in estimated glomerular filtration rate, or eGFR. The company is working with the FDA to finalize the study protocol and expects to initiate this study in the second half of 2017.
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