Cyclosporine and steroid therapy in children with steroid-resistant nephrotic syndrome.
We conducted a prospective, multicenter trial to evaluate the efficacy and safety of a 12-month course of cyclosporine in children with steroid-resistant nephrotic syndrome (SRNS). Thirty-five patients were enrolled, of whom 28 had minimal change or diffuse mesangial proliferation (MC/DMP), and seven had focal segmental glomerulosclerosis (FSGS). All patients received cyclosporine and prednisolone; patients with FSGS additionally received methylprednisolone pulse therapy (MPT). The dose of cyclosporine was adjusted to maintain a trough level of 120-150 ng/ml during the initial 3 months of treatment, followed by 80-100 ng/ml during months 4-12. The primary end point was the remission rate at month 12. Remission was achieved in 23 of 28 (82.1%) patients in the MC/DMP group and in six of the seven (85.7%) patients in the FSGS group. Follow-up renal biopsies were performed in 26 patients (nine at month 12, 17 at month 24), and cyclosporine-related nephrotoxicity was detected in one (3.8%). Major adverse events comprised severe bacterial infections (two patients) and posterior reversible encephalopathy syndrome (one patient). In conclusion, a high remission rate was achieved in our patient cohort using a combined cyclosporine/ prednisolone treatment regimen in children with SRNS who had MC/DMP and a combined cyclosporine/prednisolone plus MPT regimen in children who had FSGS.
Hamasaki
Yuko
Y
Department of Pediatric Nephrology, Tokyo Metropolitan Kiyose Children's Hospital, Kiyose-city, Japan. yu.hama@chp-kiyose-tokyo.jp
Yoshikawa
Norishige
N
Hattori
Shinzaburo
S
Sasaki
Satoshi
S
Iijima
Kazumoto
K
Nakanishi
Koichi
K
Matsuyama
Takeshi
T
Ishikura
Kenji
K
Yata
Nahoko
N
Kaneko
Tetsuji
T
Honda
Masataka
M
D000284:Administration, Oral; D001706:Biopsy; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000627:therapeutic use*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D007564:Japan; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D009404:Nephrotic Syndrome / Q000188:drug therapy* / Q000473:pathology; D011239:Prednisolone / Q000627:therapeutic use; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D013256:Steroids / Q000378:metabolism*; D013997:Time Factors; D016896:Treatment Outcome
D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D013256:Steroids; D016572:Cyclosporine; D011239:Prednisolone; D008775:Methylprednisolone