Trials / Active Not Recruiting
Active Not RecruitingNCT05746559
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
ARTEMIS: RAvulizumab to PRotect PaTients With Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 736 (estimated)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Participants will receive a single weight-based dose of placebo via intravenous infusion. |
| DRUG | Ravulizumab | Participants will receive a single weight-based dose of ravulizumab via intravenous infusion. |
Timeline
- Start date
- 2023-04-06
- Primary completion
- 2026-05-18
- Completion
- 2027-02-17
- First posted
- 2023-02-27
- Last updated
- 2026-04-13
Locations
162 sites across 21 countries: United States, Argentina, Australia, Austria, Brazil, Canada, China, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05746559. Inclusion in this directory is not an endorsement.