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

DISC-0974-103 - CKD Anemia

Sponsor: DISC

Phase: 1b

Accrual Status: Completed

HM15421/GC1134A - Fabry Disease

Sponsor: GC Biopharma

Phase: 1 and 2

D34660000001 - Lupus Nephritis 

Sponsor: AstraZeneca

Phase: 3

 

Bardoxolone-Methyl

A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome
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Finerenone

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care
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Spironolactone

A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease
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Daprodustat

A 52-week Open-label (Sponsor-blind), Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Initiating Dialysis
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Tesevatinib

A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease. The primary outcome measures are to change the height adjusted total kidney volume in ADPKD patient in two year time period. 
Click here for more information about Tesevatinib in Subjects with ADPKD

A Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects with Autosomal Dominant Polycystic Kidney Disease. The primary outcome is to analysis a two year time period of change in glomerular filtration rate (GFR) in ADPKD patients.
Click here for more information about Subjects with ADPKD

Tolvaptan

A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long -Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/Day, Split Dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease. The primary outcome is to determine the long-term safety of Tolvaptan in ADPKD patients. 
Click here for more information about Tolvaptan in Subjects with ADPKD