Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001
NCT ID: NCT02868229
Last Updated: 2021-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2016-09-12
2018-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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COR-001
COR-001
Placebo
Placebo
Interventions
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COR-001
Placebo
Eligibility Criteria
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Inclusion Criteria
2. The patient agrees to comply with the contraception and reproduction restrictions of the study
3. Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
4. At least 2 ferritin values during Screening \> 300 ng/mL
5. At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)
Exclusion Criteria
2. Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
3. Actively treated or active malignancy
4. Known or suspected occult or active bleeding
5. 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
18 Years
80 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Countries
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References
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Pergola PE, Devalaraja M, Fishbane S, Chonchol M, Mathur VS, Smith MT, Lo L, Herzog K, Kakkar R, Davidson MH. Ziltivekimab for Treatment of Anemia of Inflammation in Patients on Hemodialysis: Results from a Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2021 Jan;32(1):211-222. doi: 10.1681/ASN.2020050595. Epub 2020 Dec 3.
Pergola PE, Davidson M, Jensen C, Mohseni Zonoozi AA, Raj DS, Andreas Schytz P, Tuttle KR, Perkovic V. Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE). J Am Soc Nephrol. 2024 Jan 1;35(1):74-84. doi: 10.1681/ASN.0000000000000245. Epub 2023 Dec 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NN6018-4791
Identifier Type: -
Identifier Source: org_study_id
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