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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926117
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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
Chronic Kidney Diseases Inflammation Biological: Ziltivekimab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : June 3, 2019
Actual Primary Completion Date : June 26, 2020
Actual Study Completion Date : June 26, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo
 Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001
Experimental: Ziltivekimab 7.5 mg Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001
Experimental: Ziltivekimab 15 mg Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001
Experimental: Ziltivekimab 30 mg Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001


Outcome Measures
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Primary Outcome Measures :
  1. Inflammation [ Time Frame: 24 weeks ]
    CRP


Secondary Outcome Measures :
  1. NT-proBNB [ Time Frame: 24-weeks ]
  2. Hemoglobin [ Time Frame: 24-weeks ]
  3. Albumin [ Time Frame: 24-weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926117


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03926117    
Other Study ID Numbers: NN6018-4779
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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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:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Inflammation
 Pathologic Processes
Urologic Diseases
Renal Insufficiency