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Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03926117

Recruitment Status Completed

First Posted April 24, 2019

Last update posted February 11, 2021

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:Chronic Kidney Diseases
    Inflammation
  • Intervention/Treatment: Biological: Ziltivekimab
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 264 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • 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 2019
  • Actual Primary Completion Date: June 2020
  • Actual Study Completion Date: June 2020
Arms and interventions
Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo
Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Experimental: Ziltivekimab 15 mg
Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Experimental: Ziltivekimab 30 mg
Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Experimental: Ziltivekimab 7.5 mg
Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Outcome Measures
  • 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
  • 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
Contacts
Locations
Show 49 Study Locations
Sponsors and Collaborators

Novo Nordisk A/S

Investigators

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

More Information
  • Responsible Party: Novo Nordisk A/S
  • ClinicalTrials.gov Identifier: NCT03926117 History of Changes
  • Other Study ID Numbers: NN6018-4779
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: February 11, 2021
  • Last Verified: February 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
  • 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: Inflammation
    IL-6
    CRP
    Chronic Kidney Disease
    Cardiovascular Disease
  • Additional relevant MeSH terms: Inflammation
    Renal Insufficiency, Chronic
    Kidney Diseases
    Kidney Failure, Chronic