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

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Novo Nordisk

Status and phase

Completed
Phase 2
Phase 1

Conditions

Anemia

Treatments

Other: Placebo
Drug: COR-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT02868229
NN6018-4791

Details and patient eligibility

About

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

Enrollment

61 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

  1. Age greater than or equal to 18 years at the time of signing of the ICF.
  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:

  1. Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
  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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

61 participants in 2 patient groups, including a placebo group

COR-001
Experimental group
Treatment:
Drug: COR-001
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial documents
2

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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