Trial reportBMJ open2015
Study protocol for a phase III multicentre, randomised, open-label, blinded-end point trial to evaluate the efficacy and safety of immunoglobulin plus cyclosporin A in patients with severe Kawasaki disease (KAICA Trial).
Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 32 citations in OpenAlex.
- Predictive value of the hemoglobin-albumin-lymphocyte-platelet score for intravenous immunoglobulin resistance in children with Kawasaki disease.Italian journal of pediatrics · 2026Article
- The Potential Role of Endothelial Cells in the Pathophysiology, Diagnosis, and Management of Acute Kawasaki Disease.CJC open · 2026Review
- Article
- Multisystem inflammatory syndrome in children and Kawasaki disease.Frontiers in immunology · 2025Review
- The Negative Predictive Value of Harada Scoring for Coronary Artery Dilatation or Aneurysm in Children with Kawasaki Disease: A Cross-sectional Study.Iranian journal of medical sciences · 2022Article
- Increased Expression of Pyroptosis in Leukocytes of Patients with Kawasaki Disease.Diagnostics (Basel, Switzerland) · 2021Article
- Article
- Antibodies and Immunity During Kawasaki Disease.Frontiers in cardiovascular medicine · 2020Review
- The factors affecting the disease course in Kawasaki disease.Rheumatology international · 2019Article
- Investigation of novel variations of ORAI1 gene and their association with Kawasaki disease.Journal of human genetics · 2019Article
- Refractory Kawasaki disease: diagnostic and management challenges.Pediatric health, medicine and therapeutics · 2019Review
- Article
- Treatment Options for Resistant Kawasaki Disease.Paediatric drugs · 2018Review
- Adjunctive therapies in Kawasaki disease.International journal of rheumatic diseases · 2018Review
- Calcineurin inhibitors exacerbate coronary arteritis via the MyD88 signalling pathway in a murine model of Kawasaki disease.Clinical and experimental immunology · 2017Article
- Kawasaki disease: etiopathogenesis and novel treatment strategies.Expert review of clinical immunology · 2017Review
- The Clinical Diagnosis and Management of Kawasaki Disease: a Review and Update.Current infectious disease reports · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionKawasaki disease (KD) is an acute, self-limited vasculitis of unknown aetiology that predominantly affects infants and young children. We hypothesise that cyclosporin A (CsA) may be effective in treating KD by regulating the Ca(2+)/NFAT signalling pathway. This trial compares the current standard therapy of intravenous immunoglobulin (IVIG) and the combined IVIG+CsA therapy in paediatric patients with severe KD. METHODS AND ANALYSIS: This trial is a phase III, multicentre, randomised, open-label, blinded-end point trial that evaluates the efficacy and safety of IVIG+CsA therapy. Patients with severe KD who satisfy the eligibility criteria are randomised (1:1) to receive either CsA (5 mg/kg/day for 5 days; Neoral) plus high-dose IVIG (2 g/kg for 24 h and aspirin 30 mg/kg/day), or high-dose IVIG alone (2 g/kg for 24 h and aspirin 30 mg/kg/day). The primary end point is the frequency of occurrence of coronary artery abnormalities during the trial period. An independent end point review committee will be in charge of the trial assessment. ETHICS AND DISSEMINATION: The protocol was approved by the Institutional Review Board of each institution. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, in Japan. The trial is currently on-going and is scheduled to finish in April 2017. The findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: JMA-IIA00174; Pre-results.
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Identifiers
What OpenQuestion holds
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.