CORE Kidney

Past Clinical Trials

Completed Clinical Trials 

Omeros ARTEMIS - IgA Nephropathy

Drug name: OMS721

  • Phase 3, double-blind, placebo-controlled
  • Mechanism: the drug is an immunoglobulin G4 monoclonal antibody that binds to/inhibits mannan-binding lectin associated serine protease. Suppression of LP (lectin pathway) activation

Key inclusion criteria:

  • Age ≥ 18
  • eGFR ≥ 30
  • Proteinuria > 1g/24h

Exclusion:

  • Immunosuppressant/cytotoxic drugs/eculizumab treatment within 8 weeks prior to screening (unless given for indications other than IgAN)
  • Systemic corticosteroid treatment within 8 weeks prior to screening

Pfizer - FSGS

Drug name: PF-06730512

  • Phase 2a, open-label
  • Mechanism: acts as a SLIT neutralizing ligand trap to inhibit nephrin-induced actin polymerization

Key inclusion criteria:

  • Age > 18 years
  • eGFR > 45
  • UPCR > 1.5 g/g

Exclusion:

  • any immunosuppressant medications within 28 days prior to Lead-In period (besides corticosteroids, MMF, or CNIs)

Sanofi ACT - Alport Syndrome

Drug name: Lademirsen (SAR339375)

  • Phase 2, double-blind, placebo-controlled
  • Mechanism: inhibition of microRNS-21 to prevent fibrosis and disease progression

Key inclusion criteria:

  • Alport syndrome
  • GFR 35 – 90 at screening
  • Males 18-23 years old with eGRF < 90 OR ACE inhibitor/ARB dosing stable for 30 days prior to screening OR Prior eGFR Slope Criteria is defined as a decline in eGFR of ≥4 mL/min/1.73m2/year(eGFR slope ≤-4 mL/min/1.73m2/year)based on a linear regression slope analysis of≥4eGFR measurements within 3 years prior to the study and with a minimum of 2-yeartime span

Exclusion:

  • Significant/unstable cardiac disease in last 6 months

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