Trials / Completed
CompletedNCT03926117
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ziltivekimab | human IgG1k anti-human IL-6 monoclonal antibody |
Timeline
- Start date
- 2019-06-03
- Primary completion
- 2020-06-26
- Completion
- 2020-06-26
- First posted
- 2019-04-24
- Last updated
- 2025-12-31
- Results posted
- 2023-08-09
Locations
49 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03926117. Inclusion in this directory is not an endorsement.