RT Journal Article
SR Electronic
T1 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)
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e009562
DO 10.1136/bmjopen-2015-009562
VO 5
IS 12
A1 Reiko Aoyagi
A1 Hiromichi Hamada
A1 Yasunori Sato
A1 Hiroyuki Suzuki
A1 Yoshihiro Onouchi
A1 Ryota Ebata
A1 Kengo Nagashima
A1 Moe Terauchi
A1 Masaru Terai
A1 Hideki Hanaoka
A1 Akira Hata
YR 2015
UL http://bmjopen.bmj.com/content/5/12/e009562.abstract
AB Introduction Kawasaki 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 Ca2+/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.