Sayuri Shirai1, Naohiko Imai2, Shina Sueki3, Katsuomi Matsui4, Naoto Tominaga3, Tsutomu Sakurada3, Takashi Yasuda5, Kenjiro Kimura6, Yugo Shibagaki3. 1. Department of Nephrology and Hypertension, St. Marianna University School of Medicine Yokohama City Seibu Hospital, Yokohama, Kanagawa, Japan. sirababu@marianna-u.ac.jp. 2. Department of Nephrology and Hypertension, Kawasaki Municipal Tama Hospital, Kawasaki, Kanagawa, Japan. 3. Department of Nephrology and Hypertension, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan. 4. Department of Nephrology and Hypertension, St. Marianna University School of Medicine Yokohama City Seibu Hospital, Yokohama, Kanagawa, Japan. 5. Department of Nephrology, Kichijoji Asahi Hospital, Musashino, Tokyo, Japan. 6. Department of Nephrology, JHCO Tokyo Takanawa Hospital, Takanawa, Tokyo, Japan.
Abstract
BACKGROUND:Minimal change nephrotic syndrome (MCNS) responds well to steroids, but some patients show frequent relapses. Long-term steroid administration leads to various adverse effects. We previously reported the effectiveness in refractory nephrosis patients of administrating microemulsified CyA (ME-CyA) once before meals and setting the target value of the CyA blood concentration at 2 h after ME-CyA administration (C2) to 600-1200 ng/ml. On this trial we evaluate the effectiveness and safety of ME-CyA for suppressing relapse of adult new-onset MCNS patients using C2 monitoring. METHODS:Adult new-onset MCNS patients were randomly allocated to a ME-CyA + prednisolone group ("CyA + PSL") (n = 11) and a PSL-alone group ("PSL-alone") (n = 10). The drug administration period was 18 months followed by an observation period of 12 months. RESULTS: The duration of remission tended to be longer in CyA + PSL with C2 >600 ng/ml than in PSL-alone (P = 0.112). The relapse rate up to 18 months was significantly lower in CyA + PSL with C2 >600 ng/ml than in PSL-alone (P = 0.02). C2 was significantly higher in the patients with no relapse at 18 months than that in the patients with relapse (P = 0.048). In CyA + PSL, the total dose of PSL was significantly reduced compared with PSL-alone (P = 0.002). Cosmetic adverse effects tended to be fewer in CyA + PSL. CONCLUSIONS: The combination treatment regimen of ME-CyA and PSL with C2 >600 ng/ml has potential to be an important treatment option for adult new-onset MCNS patients. However, after ME-CyA dosage reduction and discontinuation, the relapse rate increased. It is thus necessary to establish a better dose-reduction method.
RCT Entities:
BACKGROUND: Minimal change nephrotic syndrome (MCNS) responds well to steroids, but some patients show frequent relapses. Long-term steroid administration leads to various adverse effects. We previously reported the effectiveness in refractory nephrosispatients of administrating microemulsified CyA (ME-CyA) once before meals and setting the target value of the CyA blood concentration at 2 h after ME-CyA administration (C2) to 600-1200 ng/ml. On this trial we evaluate the effectiveness and safety of ME-CyA for suppressing relapse of adult new-onset MCNS patients using C2 monitoring. METHODS: Adult new-onset MCNS patients were randomly allocated to a ME-CyA + prednisolone group ("CyA + PSL") (n = 11) and a PSL-alone group ("PSL-alone") (n = 10). The drug administration period was 18 months followed by an observation period of 12 months. RESULTS: The duration of remission tended to be longer in CyA + PSL with C2 >600 ng/ml than in PSL-alone (P = 0.112). The relapse rate up to 18 months was significantly lower in CyA + PSL with C2 >600 ng/ml than in PSL-alone (P = 0.02). C2 was significantly higher in the patients with no relapse at 18 months than that in the patients with relapse (P = 0.048). In CyA + PSL, the total dose of PSL was significantly reduced compared with PSL-alone (P = 0.002). Cosmetic adverse effects tended to be fewer in CyA + PSL. CONCLUSIONS: The combination treatment regimen of ME-CyA and PSL with C2 >600 ng/ml has potential to be an important treatment option for adult new-onset MCNS patients. However, after ME-CyA dosage reduction and discontinuation, the relapse rate increased. It is thus necessary to establish a better dose-reduction method.
Authors: C Ponticelli; G Rizzoni; A Edefonti; P Altieri; E Rivolta; S Rinaldi; L Ghio; E Lusvarghi; R Gusmano; F Locatelli Journal: Kidney Int Date: 1993-06 Impact factor: 10.612