ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

• Sponsor: Alexion (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05746559
• Collaborator: (none)
• Enrollment: 736
• Locations: 97
• Arms: 2
• Anticipated Duration (Months): 23.6
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; CKD; Cardiac Disease; Cardiopulmonary Bypass	Drug: Placebo; Drug: Ravulizumab	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 736 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Mar 2, 2023
• Anticipated Primary Completion Date: Feb 17, 2025
• Anticipated Study Completion Date: Feb 17, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.	Drug: Placebo; Participants will receive a single weight-based dose of placebo via intravenous infusion.
Experimental: Ravulizumab Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.	Drug: Ravulizumab; Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB) [Day 90 post-CPB]

Secondary Outcome Measures

1. Number of Participants Free From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) at Day 90 Post CPB [Day 90 post-CPB]

2. Number of Participants Free From Severe CSA-AKI (Kidney Disease: Improving Global Outcomes [KDIGO] Stage 2 or 3) Based on Highest Observed Serum Creatinine (sCr) Within 7 Days Post CPB [Baseline through Day 7 post-CPB]

3. Number of Participants Free From Any Severe Acute Kidney Injury (AKI) (Risk, Injury, Failure, Loss of Kidney Function, and End-Stage Kidney Disease [RIFLE] Injury or Failure Criteria) Based on Highest Observed sCr Within Day 30 Post CPB [Baseline through Day 30 post-CPB]

4. Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB [Baseline through Day 30 post-CPB]

5. Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB [Baseline through Day 30 post-CPB]

6. Number of Participants Who Experienced MAKE at Days 30, 60, and 90 (Excluding MAKE90 Based on sCysC) Post CPB [Days 30, 60, and 90 post-CPB]

7. Number of Participants Who Died or had Kidney Replacement Therapy (KRT) at Days 30, 60, and 90 Post CPB [Days 30, 60, and 90 post-CPB]

8. Number of Participants with the Highest CSA-AKI Stage Within 3 and 7 Days Post CPB [Baseline through Day 3 and Day 7 post-CPB]

9. Number of Participants Free From CSA-AKI at Days 15, 30, and 60 Post CPB [Days 15, 30, and 60 post-CPB]

10. Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB [Days 3, 7, 15, 30, 60, and 90 post-CPB]

11. Number of Participants with AKI Progression on Days 15, 30, 60, and 90 Post CPB for Those Experiencing CSA-AKI Within 7 Days Post CPB [Days 15, 30, 60, and 90 post-CPB]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion 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 (Stage 3A, 3B, or 4) for at least 3 months

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	San Francisco	California	United States	94121
2	Research Site	Washington	District of Columbia	United States	20037-2342
3	Research Site	Gainesville	Florida	United States	32610
4	Research Site	Chicago	Illinois	United States	60637
5	Research Site	Louisville	Kentucky	United States	40202
6	Research Site	Haddon Heights	New Jersey	United States	08035
7	Research Site	Rochester	New York	United States	14621
8	Research Site	Durham	North Carolina	United States	27705
9	Research Site	Cleveland	Ohio	United States	44126
10	Research Site	Dallas	Texas	United States	75390
11	Research Site	Houston	Texas	United States	77030
12	Research Site	Plano	Texas	United States	75093
13	Research Site	San Antonio	Texas	United States	78229
14	Research Site	Buenos Aires		Argentina	C1110 AAF
15	Research Site	Ciudad Autónoma de Bs. As.		Argentina	C1199ABB
16	Research Site	Cordoba		Argentina	X5000 FAL
17	Research Site	Cordoba		Argentina	X5016
18	Research Site	Corrientes		Argentina	W3400AMZ
19	Research Site	San Luis		Argentina	5700
20	Research Site	Santa Fé		Argentina	S3000EOM
21	Research Site	Brisbane		Australia	4102
22	Research Site	Canberra		Australia	2605
23	Research Site	Heidelberg		Australia	3081
24	Research Site	Monash		Australia
25	Research Site	Murdoch		Australia	6150
26	Research Site	Belo Horizonte		Brazil	30150-221
27	Research Site	Campinas		Brazil	13060-080
28	Research Site	Porto Alegre		Brazil	90620-001
29	Research Site	Ribeirão Preto		Brazil	14051-140
30	Research Site	S.J. Do Rio Preto		Brazil	15090-000
31	Research Site	Sao Paulo		Brazil	05403-000
32	Research Site	Sao Paulo		Brazil	1323001
33	Research Site	São Paulo		Brazil	04012-180
34	Research Site	Saint John	New Brunswick	Canada	E2L 4L4
35	Research Site	Hamilton	Ontario	Canada	L8L 8E7
36	Research Site	Toronto	Ontario	Canada	M5B 1W8
37	Research Site	Montreal	Quebec	Canada	H2X 0C1
38	Research Site	Montreal	Quebec	Canada	H4J 1C5
39	Research Site	Montréal	Quebec	Canada	H1T 1C8
40	Research Site	Dresden		Germany	01307
41	Research Site	Essen		Germany	45147
42	Research Site	Frankfurt am Main		Germany	60590
43	Research Site	Giessen		Germany	35392
44	Research Site	Halle (Saale)		Germany	06120
45	Research Site	Muenster		Germany	48149
46	Research Site	München		Germany	81377
47	Research Site	Trier		Germany	54292
48	Research Site	Haifa		Israel	3109601
49	Research Site	Haifa		Israel	34362
50	Research Site	Petah Tikva		Israel	4941492
51	Research Site	Ramat Gan		Israel	52621
52	Research Site	Bari		Italy	70124
53	Research Site	Milano		Italy	20121
54	Research Site	Milan		Italy	20138
55	Research Site	Napoli		Italy	80131
56	Research Site	Chuo-ku		Japan	104-8560
57	Research Site	Kamakura-shi		Japan	247-8533
58	Research Site	Kawasaki-shi		Japan	216-8511
59	Research Site	Okayama-shi		Japan	700-0804
60	Research Site	Sagamihara-shi		Japan	252-0375
61	Research Site	Suginami		Japan	168-0065
62	Research Site	Urayasu		Japan	279-0001
63	Research Site	Daegu		Korea, Republic of	41931
64	Research Site	Daegu		Korea, Republic of	42472
65	Research Site	Seoul		Korea, Republic of	02841
66	Research Site	Seoul		Korea, Republic of	03080
67	Research Site	Seoul		Korea, Republic of	06351
68	Research Site	Seoul		Korea, Republic of	120-752
69	Research Site	Bielsko-Biała		Poland	43-316
70	Research Site	Chrzanów		Poland	32-500
71	Research Site	Lodz		Poland	91-347
72	Research Site	Poznań		Poland	60-355
73	Research Site	Szczecin		Poland	70-111
74	Research Site	Tychy		Poland	43-100
75	Research Site	Łódź		Poland	92-213
76	Research Site	A Coruna		Spain	15006
77	Research Site	Barcelona		Spain	08036
78	Research Site	Córdoba		Spain	14004
79	Research Site	Madrid		Spain	28040
80	Research Site	Madrid		Spain	28041
81	Research Site	Majadahonda		Spain	28250
82	Research Site	Navarra		Spain	31190
83	Research Site	Santander		Spain	39008
84	Research Site	Sevilla		Spain	41071
85	Research Site	Hualien City		Taiwan	970473
86	Research Site	New Taipei		Taiwan	220
87	Research Site	Taichung		Taiwan	40447
88	Research Site	Tainan City		Taiwan	70403
89	Research Site	Taipei City		Taiwan	11696
90	Research Site	Ankara		Turkey	06800
91	Research Site	Istanbul		Turkey	34093
92	Research Site	Istanbul		Turkey	34303
93	Research Site	Istanbul		Turkey	34349
94	Research Site	Istanbul		Turkey	34668
95	Research Site	Istanbul		Turkey	34846
96	Research Site	Clydebank		United Kingdom	G81 4DY
97	Research Site	London		United Kingdom	W12 0HS

Sponsors and Collaborators

• Alexion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexion
• ClinicalTrials.gov Identifier: NCT05746559
• Other Study ID Numbers: D928DC00001
• First Posted: Feb 27, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alexion: Chronic Kidney Disease; CKD; Cardiac Disease; cardiopulmonary bypass
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Diseases; Ravulizumab

Study Results

No Results Posted as of Mar 1, 2023