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Cytokine Blocker

Anakinra for Cardiac Sarcoidosis (MAGiC-ART Trial)

Phase 2
Recruiting
Led By Jordana Kron, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of cardiac sarcoidosis according to the Heart Rhythm Society or the New Japanese Cardiac Sarcoidosis Guidelines (must meet one of the diagnostic pathways)
Histological diagnosis group (those with positive myocardial biopsy findings) Cardiac sarcoidosis is diagnosed histologically when endomyocardial biopsy or surgical specimens demonstrate non-caseating epithelioid granulomas.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

MAGiC-ART Trial Summary

This trial is testing whether IL-1 blockade with anakinra is safe and effective in patients with cardiac sarcoidosis.

Who is the study for?
This trial is for adults over 21 with cardiac sarcoidosis, confirmed either by tissue biopsy or clinical diagnosis according to specific guidelines. Participants must have certain heart dysfunctions and cannot be pregnant, severely anemic, have recent infections or cancer, severe kidney disease, or be on conflicting medications.Check my eligibility
What is being tested?
Researchers are testing the safety and effectiveness of Anakinra (an IL-1 receptor antagonist) in treating inflammation associated with cardiac sarcoidosis. The goal is to see if blocking the inflammatory response with this drug can help manage symptoms of the condition.See study design
What are the potential side effects?
Anakinra may cause reactions at the injection site, increased risk of infections due to immune system suppression, allergic reactions including anaphylaxis in rare cases, headache, nausea and potentially abnormal blood counts.

MAGiC-ART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with cardiac sarcoidosis.
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My heart condition was confirmed by a biopsy showing specific inflammation.
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I have signs of sarcoidosis in my lungs or eyes and at least 2 lab results confirm it.
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I have a severe heart rhythm problem.
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My heart's pumping ability is below normal.
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I have sarcoidosis only in my heart, with no symptoms in my lungs, eyes, or skin.
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My heart's inner wall has abnormal thinning or structure.
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My heart condition was confirmed by a biopsy showing specific non-caseating granulomas.
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My heart condition was confirmed by a biopsy showing specific inflammation.
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I have been diagnosed with cardiac sarcoidosis following specific guidelines.
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I likely have cardiac sarcoidosis based on specific heart issues and tests.
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My heart condition was confirmed by a tissue test showing specific inflammation without infection.
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My heart condition was confirmed by a biopsy showing specific inflammation.
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I have been diagnosed with sarcoidosis based on symptoms and lab results, without needing a heart biopsy.
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My heart condition was confirmed by a tissue diagnosis showing specific inflammation without infection.
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I show signs of sarcoidosis in my lungs or eyes and have at least 2 lab indicators.
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My lung test shows a high immune cell ratio.
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I have been diagnosed with cardiac sarcoidosis based on specific criteria.
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My heart condition was confirmed by a tissue test showing specific inflammation without infection.
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I have been diagnosed with sarcoidosis.
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I have been diagnosed with cardiac sarcoidosis following specific guidelines.
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I have swelling in the lymph nodes on both sides of my chest.

MAGiC-ART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in inflammation marker
Secondary outcome measures
Change in cardiac fibrosis
Change in cardiac inflammation
Number of serious cardiac events

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational

MAGiC-ART Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AnakinraExperimental Treatment1 Intervention
100 mg/0.67 mL daily subcutaneous injection for 4 weeks
Group II: Standard of CareActive Control1 Intervention
Continue standard of care treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
2016
Completed Phase 4
~2240

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER
320 Previous Clinical Trials
4,932,460 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
319 Previous Clinical Trials
401,703 Total Patients Enrolled
Virginia Commonwealth UniversityLead Sponsor
691 Previous Clinical Trials
22,884,725 Total Patients Enrolled

Media Library

Anakinra (Cytokine Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04017936 — Phase 2
Cardiac Sarcoidosis Research Study Groups: Anakinra, Standard of Care
Cardiac Sarcoidosis Clinical Trial 2023: Anakinra Highlights & Side Effects. Trial Name: NCT04017936 — Phase 2
Anakinra (Cytokine Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04017936 — Phase 2

Frequently Asked Questions

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

Has Anakinra received clearance from the Food and Drug Administration?

"To reflect its Phase 2 trial status, Anakinra was assigned a safety score of two due to the limited evidence backing up its efficacy."

Answered by AI

Has Anakinra been tested in previous experiments?

"Presently, there are 33 active studies researching the potential of Anakinra with 7 trials in their last phase. Though a majority of these proceedings take place within Ile-de-France's Parisian borders, this drug is being studied by researchers at 440 different sites worldwide."

Answered by AI

What is the scope of participation for this research endeavor?

"Affirmative. According to records on clinicaltrials.gov, this trial is now recruiting patients that meet the criteria; it was initially posted on October 23rd 2020 and most recently updated November 2nd 2022. This study needs 28 participants from two different medical centres."

Answered by AI

Are enrolment opportunities still available for this experiment?

"Yes, clinicaltrials.gov shows that recruitment for this trial has commenced since its original posting on October 23rd 2020 and is still ongoing as of November 2nd 2022. Enrollment requires 28 participants collected from two distinct sites."

Answered by AI

What conditions has Anakinra been known to ameliorate?

"Anakinra is commonly prescribed to treat systemic juvenile idiopathic arthritis (sjia) and neonatal-onset multisystem inflammatory disease (nomid). Additionally, this drug may be used in conjunction with steroids or interleukin-1 receptor antagonists."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Virginia Commonwealth University
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1 spots leftby Jun 2024