Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
RESCUE
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
1 other identifier
interventional
264
1 country
49
Brief Summary
Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial. The purpose of this trial is to determine a dose to select for a potential cardiovascular outcome trial with Ziltivekimab. Doses to be tested will be 7.5 mg, 15 mg and 30 mg subcutaneous monthly compared to placebo for six months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2019
Shorter than P25 for phase_2
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2019
CompletedFirst Posted
Study publicly available on registry
April 24, 2019
CompletedStudy Start
First participant enrolled
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2020
CompletedResults Posted
Study results publicly available
August 9, 2023
CompletedDecember 31, 2025
December 1, 2025
1.1 years
April 19, 2019
June 25, 2023
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels
Percent change from baseline in hs-CRP levels at week 13 are presented.
Baseline (average of the hs-CRP value prior to randomization and day 1), week 13
Secondary Outcomes (17)
Percent Change From Baseline in Serum Amyloid A (SAA)
Baseline (average of the values at week -1 and day 1), week 13
Percent Change From Baseline in Fibrinogen
Baseline (day 1), week 13
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation
From week 0 to week 32
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events
From week 0 to week 32
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI)
From week 0 to week 32
- +12 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORMatching placebo
Ziltivekimab 7.5 mg
EXPERIMENTALZiltivekimab 15 mg
EXPERIMENTALZiltivekimab 30 mg
EXPERIMENTALInterventions
human IgG1k anti-human IL-6 monoclonal antibody
Eligibility Criteria
You may qualify if:
- years of age
- Stage 3-5 CKD
- hs-CRP \> 2.0 mg/L
- Comply with contraception
You may not qualify if:
- Low neutrophil count
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (49)
Central Alabama Research
Birmingham, Alabama, 35205, United States
Aventiv Research
Mesa, Arizona, 85210, United States
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85016, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
North America Research Institute
Lynwood, California, 90262, United States
North America Research Institute
Riverside, California, 92503, United States
Apex Research of Riverside
Riverside, California, 92505, United States
North America Research Institute
San Dimas, California, 91773, United States
Western Nephrology and Metabolic Bone Disease, PC
Arvada, Colorado, 80002, United States
AMPM Research Clinic
Miami, Florida, 33169, United States
Ocala Cardiovascular Research
Ocala, Florida, 34474, United States
Florida Premier Research Institue, LLC
Winter Park, Florida, 32789, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, 30901, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Investigator Research by Design, LLC
Chicago, Illinois, 60643, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Clinical Trials of America, LLC - West Monroe
Monroe, Louisiana, 71201, United States
Capital Nephrology
Greenbelt, Maryland, 20770, United States
Onyx Clinical Research
Caro, Michigan, 48723, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
St. Clair Nephrology Research
Roseville, Michigan, 48066, United States
Nephrology Research of Michigan
Saint Clair Shores, Michigan, 48081, United States
DaVita Clinical Research
Minneapolis, Minnesota, 55404, United States
Julia and Israel Waldbaum Dialysis Center
Great Neck, New York, 11021, United States
Northport VAMC
Northport, New York, 11768, United States
DaVita Clinical Research
The Bronx, New York, 10461, United States
Mountain Kidney and Hypertension Associates
Asheville, North Carolina, 28801, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28207, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, 28277, United States
Southeastern Nephrology - Whiteville
Whiteville, North Carolina, 28472, United States
Southeastern Nephrology Associates - Wilmington
Wilmington, North Carolina, 28401, United States
Summit Research Group, LLC
Stow, Ohio, 44224, United States
Northeast Clinical Research Center
Allentown, Pennsylvania, 18104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Piedmont Research Partners, LLC
Fort Mill, South Carolina, 29707, United States
Mountain View CLinical Research - Greer
Greer, South Carolina, 29651, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923, United States
Nephrology Associates, PC
Nashville, Tennessee, 37205, United States
Renal Disease Research Institute
Dallas, Texas, 75246, United States
Vilo Research Group, Inc
Houston, Texas, 77017, United States
Biopharma Informatick Inc. Research Center
Houston, Texas, 77043, United States
Juno Research, LLC - Northwest
Houston, Texas, 77070, United States
North Hills Medical Research, Inc
North Richland Hills, Texas, 76180, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212, United States
San Antonio Kidney Disease Center Physicians Group, PLLC
San Antonio, Texas, 78229, United States
University of Vermont
Burlington, Vermont, 05401, United States
Southside Urology and Nephrology
Danville, Virginia, 25241, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Clinical Investigation Specialist, Inc
Kenosha, Wisconsin, 53142, United States
Related Publications (5)
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.
PMID: 35212585RESULTHu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
PMID: 41805697DERIVEDAherrahrou 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.
PMID: 39073758DERIVEDPergola 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.
PMID: 38088558DERIVEDRidker 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.
PMID: 34015342DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Reporting Office (1452)
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Matching placebo
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2019
First Posted
April 24, 2019
Study Start
June 3, 2019
Primary Completion
June 26, 2020
Study Completion
June 26, 2020
Last Updated
December 31, 2025
Results First Posted
August 9, 2023
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com