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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT03926117
Collaborator
(none)
264
Enrollment
49
Locations
4
Arms
12.8
Actual Duration (Months)
5.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Ziltivekimab
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Matching placebo
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 3, 2019
Actual Primary Completion Date :
Jun 26, 2020
Actual Study Completion Date :
Jun 26, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Inflammation [24 weeks]

      CRP

    Secondary Outcome Measures

    1. NT-proBNB [24-weeks]

    2. Hemoglobin [24-weeks]

    3. Albumin [24-weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Birmingham Alabama United States 35205
    2 Novo Nordisk Investigational Site Mesa Arizona United States 85210
    3 Novo Nordisk Investigational Site Phoenix Arizona United States 85016
    4 Novo Nordisk Investigational Site Phoenix Arizona United States 85018
    5 Novo Nordisk Investigational Site Lynwood California United States 90262
    6 Novo Nordisk Investigational Site Riverside California United States 92503
    7 Novo Nordisk Investigational Site Riverside California United States 92505
    8 Novo Nordisk Investigational Site San Dimas California United States 91773
    9 Novo Nordisk Investigational Site Arvada Colorado United States 80002
    10 Novo Nordisk Investigational Site Miami Florida United States 33169
    11 Novo Nordisk Investigational Site Ocala Florida United States 34474
    12 Novo Nordisk Investigational Site Winter Park Florida United States 32789
    13 Novo Nordisk Investigational Site Augusta Georgia United States 30901
    14 Novo Nordisk Investigational Site Columbus Georgia United States 31904
    15 Novo Nordisk Investigational Site Chicago Illinois United States 60643
    16 Novo Nordisk Investigational Site Iowa City Iowa United States 52242
    17 Novo Nordisk Investigational Site Monroe Louisiana United States 71201
    18 Novo Nordisk Investigational Site Greenbelt Maryland United States 20770
    19 Novo Nordisk Investigational Site Caro Michigan United States 48723
    20 Novo Nordisk Investigational Site Detroit Michigan United States 48202
    21 Novo Nordisk Investigational Site Roseville Michigan United States 48066
    22 Novo Nordisk Investigational Site Saint Clair Shores Michigan United States 48081
    23 Novo Nordisk Investigational Site Minneapolis Minnesota United States 55404
    24 Novo Nordisk Investigational Site Bronx New York United States 10461
    25 Novo Nordisk Investigational Site Great Neck New York United States 11021
    26 Novo Nordisk Investigational Site Northport New York United States 11768
    27 Novo Nordisk Investigational Site Asheville North Carolina United States 28801
    28 Novo Nordisk Investigational Site Charlotte North Carolina United States 28207
    29 Novo Nordisk Investigational Site Charlotte North Carolina United States 28277
    30 Novo Nordisk Investigational Site Whiteville North Carolina United States 28472
    31 Novo Nordisk Investigational Site Wilmington North Carolina United States 28401
    32 Novo Nordisk Investigational Site Stow Ohio United States 44224
    33 Novo Nordisk Investigational Site Allentown Pennsylvania United States 18104
    34 Novo Nordisk Investigational Site Providence Rhode Island United States 02903
    35 Novo Nordisk Investigational Site Fort Mill South Carolina United States 29707
    36 Novo Nordisk Investigational Site Greer South Carolina United States 29651
    37 Novo Nordisk Investigational Site Knoxville Tennessee United States 37923
    38 Novo Nordisk Investigational Site Nashville Tennessee United States 37205
    39 Novo Nordisk Investigational Site Dallas Texas United States 75246
    40 Novo Nordisk Investigational Site Houston Texas United States 77017
    41 Novo Nordisk Investigational Site Houston Texas United States 77043
    42 Novo Nordisk Investigational Site Houston Texas United States 77070
    43 Novo Nordisk Investigational Site North Richland Hills Texas United States 76180
    44 Novo Nordisk Investigational Site San Antonio Texas United States 78212
    45 Novo Nordisk Investigational Site San Antonio Texas United States 78229
    46 Novo Nordisk Investigational Site Burlington Vermont United States 05401
    47 Novo Nordisk Investigational Site Danville Virginia United States 25241
    48 Novo Nordisk Investigational Site Manassas Virginia United States 20110
    49 Novo Nordisk Investigational Site Kenosha Wisconsin United States 53142

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT03926117
    Other Study ID Numbers:
    • NN6018-4779
    First Posted:
    Apr 24, 2019
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novo Nordisk A/S
    IL-6
    CRP
    Chronic Kidney Disease
    Cardiovascular Disease
    Inflammation
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Kidney Failure, Chronic
    Inflammation

    Study Results

    No Results Posted as of Jul 7, 2021