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

Summary

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

Timeline

Start

2016-09-12

Primary completion

2018-12-11

Completion

2018-12-11

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs COR-001 2 mg; p = 0.002; Differences of LS Means -5.666 (95% CI -9.082 to -2.250); ANCOVA NCT02868229 ↗

registry analysis (superiority test); Placebo vs COR-001 6 mg; p <0.001; Differences of LS Means -6.913 (95% CI -10.613 to -3.214); ANCOVA NCT02868229 ↗

registry analysis (superiority test); Placebo vs COR-001 20 mg; p <0.001; Differences of LS Means -9.591 (95% CI -13.217 to -5.965); ANCOVA NCT02868229 ↗

Publications

• Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ziltivekimab	Monoclonal antibody	7.5 mg	Subcutaneous
Subject	Ziltivekimab	Monoclonal antibody	15 mg	Subcutaneous
Subject	Ziltivekimab	Monoclonal antibody	30 mg	Subcutaneous

Indications