At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 264 enrolled
Drug / intervention
Ziltivekimabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Ziltivekimab for Chronic Kidney Diseases and Inflammation. Completed, enrolled 264 participants across 49 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Diseases, Inflammation
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartJun 2019
Primary CompletionJun 2020
TodayJul 2026
First PostedApr 24, 2019
Enrollment StartJun 3, 2019
Primary CompletionJun 26, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.2 years ago
Interventions
Ziltivekimabbiological
human IgG1k anti-human IL-6 monoclonal antibody