Evidence map›Paper›PMID 33272965›Full record

Trial reportJournal of the American Society of Nephrology : JASN2021

Ziltivekimab for Treatment of Anemia of Inflammation in Patients on Hemodialysis: Results from a Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Pablo E Pergola, Matt Devalaraja, Steven Fishbane, Michel Chonchol, Vandana S Mathur, Mark T Smith, Larry Lo, Kurt Herzog, Rahul Kakkar, Michael H Davidson

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02868229 (A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001), which is not on this map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02868229 phase1 / phase2completednot on this map

A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001

TypeinterventionalSponsorNovo Nordisk A/SRan2016 to 2018Enrolled61ConditionsAnemiaArmsCOR-001, Placebo
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 73 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. KDIGO 2026 Clinical Practice Guideline for Anemia in Chronic Kidney Disease (CKD): a commentary from the European Renal Best Practice (ERBP).Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Article
  8. Review
  9. Review
  10. Review
  11. A guide to uraemic toxicity.Nature reviews. Nephrology · 2026
    Review
  12. Article
  13. Observational
  14. Mechanisms underlying atrial fibrillation in chronic kidney disease.Journal of molecular and cellular cardiology · 2025
    Review
  15. Review
  16. Effects of Clazakizumab on Anemia and Iron Metabolism in Patients with Kidney Failure.Journal of the American Society of Nephrology : JASN · 2025
    Article
  17. Article
  18. Clonal Hematopoiesis of Indeterminate Potential and Progression of CKD.Journal of the American Society of Nephrology : JASN · 2025
    Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Pablo E PergolaRenal Associates, P.A., San Antonio, Texas.
Matt DevalarajaCorvidia Therapeutics, Inc., Waltham, Massachusetts.
Steven FishbaneDivision of Nephrology, Department of Medicine, Donald and Barbara Zucker School of Medicine, Great Neck, New York.
Michel ChoncholDivision of Renal Medicine Disease and Hypertension, University of Colorado, Aurora, Colorado.
Vandana S MathurMathur Consulting, Woodside, California.
Mark T SmithNephrology Associates, Augusta, Georgia.
Larry LoCorvidia Therapeutics, Inc., Waltham, Massachusetts.
Kurt HerzogCorvidia Therapeutics, Inc., Waltham, Massachusetts.
Rahul KakkarPandion Therapeutics, Inc., Waltham, Massachusetts.
Michael H DavidsonCorvidia Therapeutics, Inc., Waltham, Massachusetts.
Donald & Barbara Zucker School of Medicine at Hofstra/Northwell · USRenal Associates P. A. · USUniversity of Colorado Anschutz Medical Campus · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with CKD who are on hemodialysis are hyporesponsive to erythropoiesis-stimulating agents (ESAs) because of anemia of inflammation. Interleukin-6 (IL-6) induced hepcidin expression is a key mediator of such inflammation.

methodsThis phase 1/2, placebo-controlled trial assessed effects of ziltivekimab, a novel anti-IL-6 ligand antibody, in patients on hemodialysis with rs855791, a single nucleotide polymorphism of the

resultsNo patient experienced dose-limiting toxicity. Four patients (two each in the 6- and 20-mg cohorts) died of a treatment-emergent adverse event. Compared with patients receiving placebo, those receiving ziltivekimab experienced significantly greater reductions of high-sensitivity C-reactive protein, serum amyloid A, and fibrinogen from baseline to end of treatment. Median ESA usage decreased by 15,000, 15,000, or 33,000 IU/wk per patient in the 2-, 6-, and 20-mg ziltivekimab cohorts, respectively, compared with no change in the placebo group. We also noted significant dose responses for decreased ESA resistance index and increased serum iron, total iron binding capacity, transferrin saturation, and serum albumin.

conclusionsZiltivekimab significantly improved markers of inflammation, reduced ESA requirements, and increased serum albumin in patients on hemodialysis with inflammation and hyporesponsiveness to ESA therapy. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001, NCT02868229.

Indexed as

AdultAgedAnemiaAntibodies, Monoclonal, HumanizedAnti-Inflammatory Agents, Non-SteroidalBiomarkersCardiovascular DiseasesDouble-Blind MethodFemaleHematinicsHepcidinsHumansInflammationInterleukin-6 InhibitorsKidney Failure, ChronicLigandsAntibodies, Monoclonal, HumanizedAnti-Inflammatory Agents, Non-SteroidalBiomarkersHematinicsHepcidinsInterleukin-6 InhibitorsLigandsSerum Albuminziltivekimabanemiacardiovascular diseasechronic kidney diseaseerythropoietin stimulating agentshemodialysisinflammation

Identifiers

PMID33272965
PMCPMC7894678
OpenAlexW3107345101

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.