Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition (RESCUE)

December 10, 2025 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Alabama Research
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Aventiv Research
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies
      • Phoenix, Arizona, United States, 85016
        • Arizona Kidney Disease and Hypertension Center
    • California
      • Lynwood, California, United States, 90262
        • North America Research Institute
      • Riverside, California, United States, 92505
        • Apex Research of Riverside
      • Riverside, California, United States, 92503
        • North America Research Institute
      • San Dimas, California, United States, 91773
        • North America Research Institute
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Western Nephrology and Metabolic Bone Disease, PC
    • Florida
      • Miami, Florida, United States, 33169
        • AMPM Research Clinic
      • Ocala, Florida, United States, 34474
        • Ocala Cardiovascular Research
      • Winter Park, Florida, United States, 32789
        • Florida Premier Research Institue, LLC
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Southeastern Clinical Research Institute, LLC
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Investigator Research by Design, LLC
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of America, LLC - West Monroe
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Capital Nephrology
    • Michigan
      • Caro, Michigan, United States, 48723
        • Onyx Clinical Research
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Roseville, Michigan, United States, 48066
        • St. Clair Nephrology Research
      • Saint Clair Shores, Michigan, United States, 48081
        • Nephrology Research of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • DaVita Clinical Research
    • New York
      • Great Neck, New York, United States, 11021
        • Julia and Israel Waldbaum Dialysis Center
      • Northport, New York, United States, 11768
        • Northport VAMC
      • The Bronx, New York, United States, 10461
        • DaVita Clinical Research
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mountain Kidney and Hypertension Associates
      • Charlotte, North Carolina, United States, 28207
        • Metrolina Nephrology Associates, PA
      • Charlotte, North Carolina, United States, 28277
        • Metrolina Nephrology Associates
      • Whiteville, North Carolina, United States, 28472
        • Southeastern Nephrology - Whiteville
      • Wilmington, North Carolina, United States, 28401
        • Southeastern Nephrology Associates - Wilmington
    • Ohio
      • Stow, Ohio, United States, 44224
        • Summit Research Group, LLC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Northeast Clinical Research Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Fort Mill, South Carolina, United States, 29707
        • Piedmont Research Partners, LLC
      • Greer, South Carolina, United States, 29651
        • Mountain View CLinical Research - Greer
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Knoxville Kidney Center, PLLC
      • Nashville, Tennessee, United States, 37205
        • Nephrology Associates, PC
    • Texas
      • Dallas, Texas, United States, 75246
        • Renal Disease Research Institute
      • Houston, Texas, United States, 77017
        • Vilo Research Group, Inc
      • Houston, Texas, United States, 77043
        • Biopharma Informatick Inc. Research Center
      • Houston, Texas, United States, 77070
        • Juno Research, LLC - Northwest
      • North Richland Hills, Texas, United States, 76180
        • North Hills Medical Research, Inc
      • San Antonio, Texas, United States, 78212
        • Clinical Advancement Center, PLLC
      • San Antonio, Texas, United States, 78229
        • San Antonio Kidney Disease Center Physicians Group, PLLC
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont
    • Virginia
      • Danville, Virginia, United States, 25241
        • Southside Urology and Nephrology
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Clinical Investigation Specialist, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age
  • Stage 3-5 CKD
  • hs-CRP > 2.0 mg/L
  • Comply with contraception

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Names:
  • COR-001
Experimental: Ziltivekimab 7.5 mg
Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Names:
  • COR-001
Experimental: Ziltivekimab 15 mg
Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Names:
  • COR-001
Experimental: Ziltivekimab 30 mg
Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Names:
  • COR-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels
Time Frame: Baseline (average of the hs-CRP value prior to randomization and day 1), week 13
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Serum Amyloid A (SAA)
Time Frame: Baseline (average of the values at week -1 and day 1), week 13
Percent change from baseline in SAA at week 13 are presented.
Baseline (average of the values at week -1 and day 1), week 13
Percent Change From Baseline in Fibrinogen
Time Frame: Baseline (day 1), week 13
Percent change from baseline in fibrinogen at week 13 are presented.
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
Time Frame: From week 0 to week 32
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAEs are defined as AEs that initiated or worsened on or after the date of first dose of study drug up to the end of safety-follow-up. A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. TEAEs that met any of these criteria were considered severe hematologic AEs: grade 3 neutropenia, grade 3 anemia, grade 3 leukopenia, grade 3 lymphopenia, grade 3 eosinophilia, and grade 3 thrombocytopenia.
From week 0 to week 32
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events
Time Frame: From week 0 to week 32
Bleeding events were classified using the TIMI bleeding classification as follows: 1) major: intracranial hemorrhage or a >=5 g/dL decrease in the hemoglobin concentration or a >=15 percent (%) absolute decrease in the hematocrit; 2) minor: (a) observed blood loss: >=3 g/dL decrease in the hemoglobin concentration or >=10% decrease in the hematocrit. (b) no observed blood loss: >=4 g/dL decrease in the hemoglobin concentration or >=12% decrease in the hematocrit; 3) minimal: any clinically overt sign of hemorrhage (including imaging) that was associated with a < 3 g/dL decrease in the hemoglobin concentration or <9% decrease in the hematocrit.
From week 0 to week 32
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI)
Time Frame: From week 0 to week 32
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AESI included serious infections, malignancies, anaphylaxis occurring at any time, even if considered unrelated to the study drug, gastrointestinal perforations, hypersensitivity reaction during investigational product (IP) administration, neutrophils per cubic millimeter (500/mm^3) (severe) or neutrophils <1000/mm^3 (severe) with evidence of concurrent infection, severe injection-related reactions, thrombocytopenia (platelet count <50,000/mm^3 (severe)) or platelet count <75,000/mm^3 (moderate) with evidence of concurrent TIMI major bleeding.
From week 0 to week 32
Change in Systolic Blood Pressure (SBP)
Time Frame: Baseline (week 1), week 32
Change from baseline in systolic blood pressure at week 32 are presented.
Baseline (week 1), week 32
Change in Diastolic Blood Pressure (DBP)
Time Frame: Baseline (week 1), week 32
Change from baseline in diastolic blood pressure at week 32 are presented.
Baseline (week 1), week 32
Change in Respiratory Rate
Time Frame: Baseline (week 1), week 32
Change from baseline in respiratory rate at week 32 are presented.
Baseline (week 1), week 32
Change in Body Mass Index (BMI)
Time Frame: Baseline (week 1), week 24
Change from baseline in BMI at week 24 are presented.
Baseline (week 1), week 24
Change in Heart Rate
Time Frame: Baseline (week 1), week 32
Change from baseline in heart rate at Week 32 are presented.
Baseline (week 1), week 32
Change in Temperature
Time Frame: Baseline (week 1), week 32
Change from baseline in temperature at week 32 are presented.
Baseline (week 1), week 32
Change in Electrocardiogram (ECG)
Time Frame: Baseline (week -1), Week 24
The ECG was assessed by the investigator at baseline (week -1) and week 24 and categorised as abnormal clinically significant, abnormal not clinically significant, indeterminate, normal, not evaluable and unknown. Number of participants in each ECG category at baseline and week 24 are presented.
Baseline (week -1), Week 24
Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels
Time Frame: Baseline (week 1), week 32
Change from baseline in ALP, ALT and AAT levels at week 32 are presented.
Baseline (week 1), week 32
Change in Bicarbonate, Chloride, Potassium, Sodium
Time Frame: Baseline (week 1), week 32
Change from baseline in bicarbonate, chloride, potassium, sodium at week 32 are presented.
Baseline (week 1), week 32
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen
Time Frame: Baseline (week 1), week 32
Change from baseline in direct bilirubin, bilirubin, calcium, creatinine, glucose, phosphate and urea nitrogen at week 32 are presented.
Baseline (week 1), week 32
Follicle Stimulating Hormone (FSH) Levels
Time Frame: Baseline (week -1)
FSH levels at baseline (week -1) are presented.
Baseline (week -1)
Number of Participants With Anti-drug Antibodies (ADAs)
Time Frame: From week 0 to week 32
Participants who had at least 1 positive sample (treatment-boosted or treatment-induced) at any time after their first Ziltivekimab administration were classified as positive for ADAs. In the instance that a participant had a positive sample at the baseline visit, the participant was considered positive only if the peak titer of the post-treatment sample was at least 2-fold higher (i.e., >=2-fold) than the titer of the baseline sample. Number of participants positive for antibodies to Ziltivekimab are presented.
From week 0 to week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2019

Primary Completion (Actual)

June 26, 2020

Study Completion (Actual)

June 26, 2020

Study Registration Dates

First Submitted

April 19, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN6018-4779

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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