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Monoclonal Antibodies

Ravulizumab for Kidney Damage from Heart Surgery (ARTEMIS Trial)

Phase 3
Recruiting
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant weighs ≥ 30 kg
Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3, 7, 15, 30, 60, and 90 post-cpb
Awards & highlights

ARTEMIS Trial Summary

This trial studies the effects of a single dose of a drug to reduce the risk of kidney damage from heart surgery.

Who is the study for?
This trial is for adults with chronic kidney disease (CKD stages 3A, 3B, or 4) who weigh at least 30 kg and are scheduled for non-emergency heart surgery using cardiopulmonary bypass. Candidates should not have used certain kidney treatments or had infections recently and must be willing to get vaccinated against N meningitidis if needed.Check my eligibility
What is being tested?
The ARTEMIS study is testing whether a single dose of ravulizumab given intravenously can reduce the risk of acute kidney injury after heart surgery compared to a placebo. The focus is on seeing if this treatment helps avoid major adverse kidney events within 90 days post-surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, ravulizumab may cause reactions related to the immune system such as increased infection risk. Participants will also need vaccinations against N meningitidis due to potential immunosuppression.

ARTEMIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 30 kilograms.
Select...
I have been diagnosed with moderate to severe kidney disease for at least 3 months.
Select...
I am scheduled for heart surgery that may include bypass or valve repair.

ARTEMIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 3, 7, 15, 30, 60, and 90 post-cpb
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3, 7, 15, 30, 60, and 90 post-cpb for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)
Secondary outcome measures
Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB
Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB
Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB
+8 more

Side effects data

From 2022 Phase 3 trial • 195 Patients • NCT03056040
31%
Headache
30%
Nasopharyngitis
28%
Upper respiratory tract infection
21%
Fatigue
19%
Diarrhoea
19%
Pyrexia
18%
Nausea
17%
Cough
15%
Abdominal pain
14%
Back pain
14%
Dizziness
13%
Pain in extremity
11%
Arthralgia
11%
Influenza like illness
10%
Oropharyngeal pain
10%
Rhinitis
8%
Vomiting
8%
Abdominal pain upper
8%
Dyspnoea
8%
Urinary tract infection
8%
Anaemia
7%
Constipation
6%
Chest pain
6%
Dysphagia
5%
Gastroenteritis
5%
Pruritus
5%
Myalgia
5%
Palpitations
5%
Influenza
3%
Haemolysis
2%
Lower respiratory tract infection
2%
Haemolytic anaemia
1%
Hyperthermia
1%
Cholelithiasis
1%
Foot deformity
1%
Basal cell carcinoma
1%
Colitis
1%
Bone marrow failure
1%
Infection
1%
Pneumonia
1%
Post procedural infection
1%
Liver disorder
1%
Depression
1%
Epilepsy
1%
Respiratory failure
1%
Enteritis
1%
Pneumoperitoneum
1%
Toothache
1%
Bile duct stone
1%
Biliary colic
1%
Cholecystitis
1%
COVID-19
1%
Bacteraemia
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Pneumonia bacterial
1%
Postoperative wound infection
1%
Rhinovirus infection
1%
Septic shock
1%
Ankle fracture
1%
Ligament injury
1%
Transfusion reaction
1%
Cerebrospinal fluid retention
1%
Loss of consciousness
1%
Dupuytren's contracture
1%
Intervertebral disc degeneration
1%
Osteonecrosis
1%
Ureterolithiasis
1%
Urinary retention
1%
Major depression
1%
Suicide attempt
1%
Dermal cyst
1%
Invasive papillary breast carcinoma
1%
Aplastic anaemia
1%
Breakthrough haemolysis
1%
Tibia fracture
1%
Lower limb fracture
1%
Deep vein thrombosis
1%
Endometrial cancer
1%
Lung cancer metastatic
1%
Renal cancer metastatic
1%
Seborrhoeic keratosis
1%
Pharyngitis
1%
Pneumococcal infection
1%
Liver function test increased
1%
Road traffic accident
1%
Suspected COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab
Eculizumab

ARTEMIS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RavulizumabExperimental Treatment1 Intervention
Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2021
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
252 Previous Clinical Trials
40,409 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
38,534 Total Patients Enrolled

Media Library

Ravulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05746559 — Phase 3
Cardiovascular Disease Research Study Groups: Placebo, Ravulizumab
Cardiovascular Disease Clinical Trial 2023: Ravulizumab Highlights & Side Effects. Trial Name: NCT05746559 — Phase 3
Ravulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746559 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Ravulizumab received official sanction from the FDA?

"Our team's assessment of Ravulizumab's safety earned it a score of 3, since the Phase 3 trial results have demonstrated its effectiveness and there is ample evidence supporting its security."

Answered by AI

Is enrollment for this research investigation still open?

"Data from clinicaltrials.gov reveals that, as of February 27th 2023, this research is not actively enrolling patients. Despite this, there are still 850 other studies seeking participants at the present time."

Answered by AI

Are participants of this trial restricted to a certain age limit?

"This medical trial requires that participants are between the ages of 18 to 90. Conversely, there is an additional 130 trials for people under eighteen and 734 studies available for those who are elderly."

Answered by AI

What are the geographic locations in which this clinical trial is being conducted?

"At present, 84 medical centres across the United States are participating in this trial. In addition to Washington, Gainesville and Chicago, many other cities have clinics open for recruitment. It is advised that participants select a local clinic to minimize travel requirements."

Answered by AI

Am I eligible to be a part of this clinical investigation?

"Patients must have chronic kidney disease, a minimum age of 18 and be no older than 90 to qualify for this trial. There are 736 participants being enrolled in total."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~335 spots leftby Feb 2025