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