Centessa Reports the First Patient Dosing in the P-III (ACTION) Study of Lixivaptan for Autosomal Dominant Polycystic Kidney Disease
Shots:
- The first patient has been dosed in the P-III (ACTION) study to evaluate lixivaptan vs PBO in 1350 patients with ADPKD at 200+ sites in ~20 countries. The patient enrollment is expected to be complete in H2’23
- The 1EPs is to assess lixivaptan in slowing the decline in renal function as measured by the difference in eGFR @ 52wks., patients who completed Part 1 are expected to enter into Part 2 & will be treated for an additional year to evaluate the sustainability of the benefit on eGFR change @2yr.
- Additionally, IDMC will review safety data including the liver chemistry data. The company also plans to submit an NDA after completion of the 1yr. double-blind portion of the study
Ref: Globe Newswire | Image: Businesswire
Click here to read the full press release
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com