Evidence map›Paper›PMID 27080929›Full record

Trial reportContemporary clinical trials2016

Rationale and study design for a phase I/IIa trial of anakinra in children with Kawasaki disease and early coronary artery abnormalities (the ANAKID trial).

Adriana H Tremoulet, Sonia Jain, Susan Kim, Jane Newburger, Moshe Arditi, Alessandra Franco, Brookie Best, Jane C Burns

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02179853 (Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease), which is not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
9.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02179853 phase1 / phase2completednot on this map

Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

TypeinterventionalSponsorUniversity of California, San DiegoRan2014 to 2022Enrolled22ConditionsKawasaki DiseaseArmsAnakinra
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  10. Inflammatory factors collaboratively linkFrontiers in immunology · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Adriana H TremouletKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA, USA; Rady Children's Hospital San Diego, San Diego, CA, USA. Electronic address: atremoulet@ucsd.edu.
Sonia JainBiostatistics Research Center, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, USA.
Susan KimRheumatology Program, Division of Immunology, Boston Children's Hospital, Boston, MA, USA.
Jane NewburgerDepartment of Cardiology, Harvard Medical School, Boston, MA, USA; Department of Pediatrics, Children's Hospital of Boston, Boston, MA, USA.
Moshe ArditiDepartment of Pediatrics, Cedars Sinai Medical Center, USA; UCLA School of Medicine, USA.
Alessandra FrancoDepartment of Pediatrics, University of California San Diego, La Jolla, CA, USA.
Brookie BestDepartment of Pediatrics, University of California San Diego, La Jolla, CA, USA; Skaggs School of Pharmacy, La Jolla, CA, USA.
Jane C BurnsKawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA, USA; Rady Children's Hospital San Diego, San Diego, CA, USA.
University of California San Diego · USBoston Children's Hospital · USCedars-Sinai Medical Center · US

Funding

Role of IL-1 in Bacterial ligand-induced vasculitis and myocarditisR01AI072726 · NIAID · CEDARS-SINAI MEDICAL CENTER · PI ARDITI, MOSHE · 2008 to 2020
$4.5M
Safety and Dose Optimization of High-Dose Anakinra in Kawasaki DiseaseU54HD090259 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI NIGAM, SANJAY K · 2016 to 2018
$2.2M
Safety and Dose Optimization of High-Dose Anakinra in Kawasaki DiseaseP50HD090259 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI NIGAM, SANJAY K · 2019 to 2020
$1.4M
NIAID NIH HHS R01 AI072726NICHD NIH HHS P50 HD090259NICHD NIH HHS U54 HD090259
6 · The paper itself

Abstract

backgroundAlthough Kawasaki disease (KD) is the most common cause of acquired heart disease in children and may result in coronary artery aneurysms (CAA) with an attendant risk of myocardial infarction, there is no recommended therapy to halt progression of arterial wall damage and prevent aneurysm formation in the acute phase of the vasculitis. While intravenous immunoglobulin (IVIG) reduces the risk of CAA, up to 20% of KD patients are IVIG resistant and have a higher risk for developing CAA. The IL-1 pro-inflammatory pathway is upregulated in children with acute KD and plays a critical role in the experimental animal model of KD. Thus, IL-1 is a logical therapeutic target.

objectivesThe goal of this study is to determine the safety, tolerability, pharmacokinetics, and immunomodulatory effects of anakinra, a recombinant human IL-1 receptor antagonist, in acute KD patients with coronary artery abnormalities on the baseline echocardiogram.

designThis is a two-center dose-escalation Phase I/IIa trial in 30 acute KD patients ≥8months old with a coronary artery Z score≥3.0 in the right coronary artery and/or left anterior descending artery or an aneurysm. Subjects will receive a 2- to 6-week course of anakinra by daily subcutaneous injection and will be assessed for resolution of inflammation and dose limiting toxicities (leukopenia, anaphylactoid reaction, or severe infection).

conclusionThe safety and tolerability of blocking both IL-1α and Il-1β by anakinra will be evaluated as a strategy to prevent or attenuate coronary artery damage in infants and children with acute KD.

trial registrationClinical Trials.gov # NCT02179853, registered June 28, 2014.

Indexed as

Antirheumatic AgentsChild, PreschoolCoronary AneurysmCoronary VesselsHumansImmunoglobulins, IntravenousImmunologic FactorsInfantInterleukin 1 Receptor Antagonist ProteinMucocutaneous Lymph Node SyndromeOrgan SizeAntirheumatic AgentsImmunoglobulins, IntravenousImmunologic FactorsInterleukin 1 Receptor Antagonist ProteinAnakinraCoronary artery aneurysmInterleukin 1Kawasaki disease

Identifiers

PMID27080929
PMCPMC5221485
OpenAlexW2324667434

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.