Palladio Alert - ADPKD

Drug name: Lixivaptan

  • Phase 3, open-label
  • Mechanism: selective vasopressin 2 receptor antagonist

Key inclusion criteria: ADPKD with previous treatment using tolvaptan

  • Age 18 – 65
  • eGFR > 20
  • at least 2 elevated ALT levels (one 2 times the the ULN and one 3 times the ULN while on tolvaptan)
  • OR based on baseline, two elevated ALT levels
  • OR a pattern of ALT elevations with no other explanation

Exclusion:

  • Prior use of tolvaptan within 3 months of screening or until a previously elevated ALT level has returned to < 1xULN for at least 3 months

Reata Falcon - ADPKD

Drug name: Bardoxolone methyl

  • Phase 3, double-blind, placebo-controlled
  • Mechanism: activator of the Nrf2 pathway, inhibitor of the NF-KB pathway
    • Promotes resolution of inflammation

Key inclusion criteria:

  • Age: 18-70 (inclusive)
  • eGFR: 30-90 (ages 18 to 55) and 30-44 (ages 56 to 70)
  • UACR < 2500 mg/g

Exclusion:

  • Concomitant use of tolvaptan (patients must be off tolvaptan for 3 months prior to screening)
  • Must be off somatostatin analogues for 3 months prior to screening