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Anakinra for Macrophage Activation Syndrome (MAS Trial)
Phase 1
Waitlist Available
Led By Randall Q Cron, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post enrollment
Awards & highlights
MAS Trial Summary
This trial is testing whether a drug called anakinra is safe and effective in treating severe inflammation caused by macrophage activation syndrome.
Who is the study for?
This trial is for hospitalized patients with severe inflammation known as Macrophage Activation Syndrome (MAS). Eligible participants include those with central nervous system dysfunction, low platelet count, liver enlargement, or high serum ferritin and other lab criteria. Patients must not be on pressors, ventilators, have a family history of HLH, systemic infections at screening time, certain organ dysfunctions or previous MAS treatments.Check my eligibility
What is being tested?
The study tests if anakinra injections alongside standard treatment are safe for treating MAS without increasing infection risks or mortality. Anakinra mimics IL-1ra to regulate inflammation. The trial compares it against a placebo and measures side effects, inflammation markers reduction, steroid dosage needed and hospital stay duration.See study design
What are the potential side effects?
Potential side effects may include increased risk of infections due to immune response suppression by anakinra. Other unanticipated reactions could occur; the study aims to identify these by monitoring patients' health throughout the trial.
MAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of acquired infections, deaths in treatment group vs placebo group
Secondary outcome measures
Normalization of elevations of MAS activity markers in treatment group vs placebo group
Total corticosteroid use and chemotherapy rescue treatment in anakinra treated group vs placebo treated group
Side effects data
From 2018 Phase 2 & 3 trial • 104 Patients • NCT0180913219%
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
MAS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: anakinra (Kineret)Experimental Treatment1 Intervention
methylprednisolone intravenously, anakinra shots every 6 hours
Group II: placeboPlacebo Group1 Intervention
methylprednisolone intravenously, placebo shots every 6 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
kineret
2008
N/A
~40
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,004 Total Patients Enrolled
Randall Q Cron, MDPrincipal InvestigatorChildren's Hospital of Alabama
Walter W Chatham, MDPrincipal InvestigatorUniversity of Alabama Hospital
1 Previous Clinical Trials
32 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cancer.My spleen is enlarged.I have been diagnosed with sJIA and meet the criteria for a severe immune response.I need medication to manage low blood pressure.I meet at least three clinical or lab criteria.I often have unexplained bruises or bleed easily.This criterion does not apply to me.I have never been diagnosed with sJIA, my ferritin levels are above 2,000 ng/ml.My liver is enlarged, extending 3 cm or more below my ribcage.I have a fever of 101°F or higher.I am under 1 year old.My family has a history of familial HLH.I experience severe brain-related symptoms like confusion or seizures.We will consider any of the following as evidence.You are currently using a machine to help you breathe.I have been treated with specific medications for my current medical condition.
Research Study Groups:
This trial has the following groups:- Group 1: placebo
- Group 2: anakinra (Kineret)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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