Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
NCT ID: NCT03926117
Last Updated: 2025-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
264 participants
INTERVENTIONAL
2019-06-03
2020-06-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo
Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Ziltivekimab 7.5 mg
Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Ziltivekimab 15 mg
Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Ziltivekimab 30 mg
Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Interventions
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Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage 3-5 CKD
* hs-CRP \> 2.0 mg/L
* Comply with contraception
Exclusion Criteria
* Low platelet count
* Spot urine protein to creatinine ration \> 4000 mg/g
* ALT/AST \>2.5x ULN
* TSAT \< 10%
* Positive TB test
* Evidence of HIV, hepatitis B
* Blind or illiterate
* Expected to require blood transfusion
* Thromboembolic event within 12-weeks
* Evidence of active infection
* Peptic ulcer disease, diverticulitis, inflammatory bowel disease
* Uncontrolled hypertension
* Planned coronary revascularization
* Major cardiac surgery, CHF
* Active malignancy, bone marrow or organ transplant
* Allergy to study drug
* Treatment with investigational drug, treatment with HIF stabilizer or ESA
* Use of immunosuppressive drugs, systemic antibiotics
* Breastfeeding, any other significant medical history
18 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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Central Alabama Research
Birmingham, Alabama, United States
Aventiv Research
Mesa, Arizona, United States
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, United States
Elite Clinical Studies
Phoenix, Arizona, United States
North America Research Institute
Lynwood, California, United States
North America Research Institute
Riverside, California, United States
Apex Research of Riverside
Riverside, California, United States
North America Research Institute
San Dimas, California, United States
Western Nephrology and Metabolic Bone Disease, PC
Arvada, Colorado, United States
AMPM Research Clinic
Miami, Florida, United States
Ocala Cardiovascular Research
Ocala, Florida, United States
Florida Premier Research Institue, LLC
Winter Park, Florida, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Investigator Research by Design, LLC
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Clinical Trials of America, LLC - West Monroe
Monroe, Louisiana, United States
Capital Nephrology
Greenbelt, Maryland, United States
Onyx Clinical Research
Caro, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
St. Clair Nephrology Research
Roseville, Michigan, United States
Nephrology Research of Michigan
Saint Clair Shores, Michigan, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Julia and Israel Waldbaum Dialysis Center
Great Neck, New York, United States
Northport VAMC
Northport, New York, United States
DaVita Clinical Research
The Bronx, New York, United States
Mountain Kidney and Hypertension Associates
Asheville, North Carolina, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, United States
Southeastern Nephrology - Whiteville
Whiteville, North Carolina, United States
Southeastern Nephrology Associates - Wilmington
Wilmington, North Carolina, United States
Summit Research Group, LLC
Stow, Ohio, United States
Northeast Clinical Research Center
Allentown, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Piedmont Research Partners, LLC
Fort Mill, South Carolina, United States
Mountain View CLinical Research - Greer
Greer, South Carolina, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
Nephrology Associates, PC
Nashville, Tennessee, United States
Renal Disease Research Institute
Dallas, Texas, United States
Vilo Research Group, Inc
Houston, Texas, United States
Biopharma Informatick Inc. Research Center
Houston, Texas, United States
Juno Research, LLC - Northwest
Houston, Texas, United States
North Hills Medical Research, Inc
North Richland Hills, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
San Antonio Kidney Disease Center Physicians Group, PLLC
San Antonio, Texas, United States
University of Vermont
Burlington, Vermont, United States
Southside Urology and Nephrology
Danville, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Clinical Investigation Specialist, Inc
Kenosha, Wisconsin, United States
Countries
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References
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Kreiner FF, Kraaijenhof JM, von Herrath M, Hovingh GKK, von Scholten BJ. Interleukin 6 in diabetes, chronic kidney disease, and cardiovascular disease: mechanisms and therapeutic perspectives. Expert Rev Clin Immunol. 2022 Apr;18(4):377-389. doi: 10.1080/1744666X.2022.2045952. Epub 2022 Mar 1.
Aherrahrou R, Reinberger T, Hashmi S, Erdmann J. GWAS breakthroughs: mapping the journey from one locus to 393 significant coronary artery disease associations. Cardiovasc Res. 2024 Nov 5;120(13):1508-1530. doi: 10.1093/cvr/cvae161.
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.
Ridker PM, Devalaraja M, Baeres FMM, Engelmann MDM, Hovingh GK, Ivkovic M, Lo L, Kling D, Pergola P, Raj D, Libby P, Davidson M; RESCUE Investigators. IL-6 inhibition with ziltivekimab in patients at high atherosclerotic risk (RESCUE): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2021 May 29;397(10289):2060-2069. doi: 10.1016/S0140-6736(21)00520-1. Epub 2021 May 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NN6018-4779
Identifier Type: -
Identifier Source: org_study_id