Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Anemia

In brief

This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo

Key facts

Study ID

NCT02868229

Run by

Novo Nordisk A/S

People needed

61

Starts

2016-09-12

Expected to finish

2018-12-11

Last updated by the study team

2021-07-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 18 years at the time of signing of the ICF.
• The patient agrees to comply with the contraception and reproduction restrictions of the study
• Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
• At least 2 ferritin values during Screening > 300 ng/mL
• At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)

You may not qualify if…

• Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
• Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
• Actively treated or active malignancy
• Known or suspected occult or active bleeding
• Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during the study

Where it is running

• Novo Nordisk Investigational Site — Northridge, California, United States
• Novo Nordisk Investigational Site — Hollywood, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Augusta, Georgia, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — North Brunswick, New Jersey, United States
• Novo Nordisk Investigational Site — Astoria, New York, United States
• Novo Nordisk Investigational Site — Fresh Meadows, New York, United States
• Novo Nordisk Investigational Site — Great Neck, New York, United States
• Novo Nordisk Investigational Site — Providence, Rhode Island, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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