Trials / Terminated
TerminatedNCT03744910
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This trial investigates the efficacy and safety of clazakizumab \[an anti-interleukin (IL)-6 monoclonal antibody (mAb)\] for the treatment of CABMR in recipients of a kidney transplant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Clazakizumab | Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6 |
| DRUG | Physiologic saline solution | Normal saline |
Timeline
- Start date
- 2019-10-14
- Primary completion
- 2024-04-08
- Completion
- 2024-04-08
- First posted
- 2018-11-19
- Last updated
- 2025-07-23
- Results posted
- 2025-07-23
Locations
142 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Netherlands, New Zealand, South Korea, Spain, Sweden, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03744910. Inclusion in this directory is not an endorsement.