Clinical Trials List
2023-03-01 - 2025-10-12
Phase III
Not yet recruiting4
Recruiting3
ICD-10N17.0
Acute kidney failure with tubular necrosis
ICD-9584.5
Acute renal failure, with lesion of tubular necrosis
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
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳怡儒 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Yuh-Mou Sue Division of Nephrology
- 張得一 Division of Cardiovascular Surgery
- Chung-Te Liu Division of Nephrology
- Chung-Yi Cheng Division of Nephrology
- 李紹榕 Division of Cardiovascular Surgery
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 張睿智 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王植賢 Division of Cardiovascular Surgery
- YIH-SHARNG CHEN Division of Cardiovascular Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 周煜倫 Division of Cardiovascular Surgery
- 黃寬如 Division of Cardiovascular Surgery
- 陳彥佑 Division of Cardiovascular Surgery
- Chien-Hsing Wu Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
‧ Ethnic group: Adult participants with CKD as defined by inclusion and exclusion criteria
‧ Indicator/variable: MAKE on day 90 after CPB (MAKE90), defined as meeting at least one of the following conditions:
o Decrease in estimated glomerular filtration rate (eGFR) from baseline (using CKD-EPI formula)
≥ 25% on the 90th day after CPB, or
o From the start of KRT to the 90th day after CPB, or
o Death from any cause up to day 90 after CPB
‧ Concurrent events (IE):
o IE1: Exposure to iodinated contrast media after treatment administration until day 90 post-CPB
o IE2: Surgery without CPB, or surgery with CPB not performed within 15 days of treatment administration
o IE3: Use of interfering intervention before surgery or use of non-permissible intervention after treatment administration until day 90 post-CPB
Treatment Policy Strategy: Collected indicators will be analyzed regardless of IE.
‧ Summary Methods: Differences between treatment groups in the proportion of participants experiencing MAKE at 90 days post-CPB
, regardless of whether any IE occurs.
Inclution Criteria
Participant weighs ≥ 30 kg
Planned non-emergent sternotomy with CPB procedure for the following surgeries:
Multi-vessel CABG
Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair
Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)
Exclusion Criteria
Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator.
Single-vessel CABG without valve surgery is planned.
Off-pump surgery is planned (eg, surgery without CPB).
Recipient of a solid organ or bone marrow transplantation.
Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
History of unexplained, recurrent infection.
Any use of KRT or presence of AKI within 30 days of randomization
Use of any complement inhibitors, or plasmapheresis or plasma exchange within the year prior to Screening, or planned use during the course of the study.
Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed
History of or unresolved N meningitidis infection.
The Estimated Number of Participants
-
Taiwan
56 participants
-
Global
736 participants
