they underwent a screening examinat

they underwent a screening examination and were registered
once their eligibility, including steroid sensitivity, was verified. The rituximab group received intravenous rituximab of
375 mg/m 2 body surface area (maximum 500 mg) once
weekly for 4 weeks, and the placebo group received placebo
at the same frequency.Prednisolonetreatmentwasgradually
discontinued after obtaining remission, and patients were
treated with prednisolone when they developed relapses
during the study period.TaperingoftheCyAdosewasstarted
on day 85, and the drug was discontinued by day 169. Other
immunosuppressive agents were discontinued by day 85.All
of the patients were observed for 1 year, unless the patients
dropped out of the study. Patients were considered to have
treatment failureif (1)relapse occurred by Day 85,(2)FRNS
orSDNSwas diagnosdbet ween Day 86 and Day 365,or(3)
steroid resistance was diagnosed during the observation
period. The primary endpoint was the relapse-free period.
The secondary endpoints were time-to-treatment failure,
relapse rate, time to FRNS/SDNS, and steroid dose after
randomization. Safety endpoints, including frequency and
severity of adverse events, were also evaluated. A gold
standard, double-blind, placebo-controlled trial was adopted
because the use of rituximab in treatment of nephrotic syn-
drome was not yet approved in any country. In the trial,
treatment failures were defined, and in the event that patients
had treatment failure, the allocation code was urgently dis-
closed. If patients were allocated to the placebo group, they
were able to enter a separately conducted rituximab pharmacokinetic trial (RCRNS02) after discontinuation or completion of RCRNS01.

Hasil (Bahasa Indonesia) 1:

they underwent a screening examination and were registeredonce their eligibility, including steroid sensitivity, was verified. The rituximab group received intravenous rituximab of375 mg/m 2 body surface area (maximum 500 mg) onceweekly for 4 weeks, and the placebo group received placeboat the same frequency.Prednisolonetreatmentwasgraduallydiscontinued after obtaining remission, and patients weretreated with prednisolone when they developed relapsesduring the study period.TaperingoftheCyAdosewasstartedon day 85, and the drug was discontinued by day 169. Otherimmunosuppressive agents were discontinued by day 85.Allof the patients were observed for 1 year, unless the patientsdropped out of the study. Patients were considered to havetreatment failureif (1)relapse occurred by Day 85,(2)FRNSorSDNSwas diagnosdbet ween Day 86 and Day 365,or(3)steroid resistance was diagnosed during the observationperiod. The primary endpoint was the relapse-free period.The secondary endpoints were time-to-treatment failure,relapse rate, time to FRNS/SDNS, and steroid dose afterrandomization. Safety endpoints, including frequency andseverity of adverse events, were also evaluated. A goldstandard, double-blind, placebo-controlled trial was adoptedbecause the use of rituximab in treatment of nephrotic syn-drome was not yet approved in any country. In the trial,treatment failures were defined, and in the event that patientspengobatan kegagalan, kode alokasi adalah mendesak dis-ditutup. Jika pasien yang dialokasikan untuk kelompok plasebo, merekamampu untuk masuk secara terpisah dilakukan rituximab pharmacokinetic sidang (RCRNS02) setelah penghentian atau penyelesaian RCRNS01.

Hasil (Bahasa Indonesia) 2:

mereka menjalani pemeriksaan skrining dan terdaftar
sekali kelayakan mereka, termasuk sensitivitas steroid, telah diverifikasi. Kelompok rituximab menerima rituximab intravena
375 mg / m 2 luas permukaan tubuh (maksimum 500 mg) sekali
seminggu selama 4 minggu, dan kelompok plasebo menerima plasebo
pada saat yang sama frequency.Prednisolonetreatmentwasgradually
dihentikan setelah mendapat remisi, dan pasien
diobati dengan prednisolon saat mereka mengembangkan kambuh
selama studi period.TaperingoftheCyAdosewasstarted
pada hari 85, dan obat dihentikan oleh hari 169. Lain
agen imunosupresif dihentikan oleh hari 85.All
pasien diamati selama 1 tahun, kecuali pasien
putus studi. Pasien dianggap memiliki
pengobatan failureif (1) kekambuhan terjadi by Day 85, (2) SNKS
orSDNSwas diagnosdbet Ween Hari 86 dan Hari 365, atau (3)
resistensi steroid didiagnosis selama pengamatan
periode. Titik akhir primer adalah periode kambuh-bebas.
Titik akhir sekunder adalah waktu-untuk-kegagalan pengobatan,
tingkat kambuh, waktu untuk SNKS / SDN, dan dosis steroid setelah
pengacakan. Endpoint keamanan, termasuk frekuensi dan
keparahan efek samping, juga dievaluasi. Sebuah emas
standar, double-blind, plasebo-terkontrol diadopsi
karena penggunaan rituximab dalam pengobatan nefrotik sindrom
drome belum disetujui di negara manapun. Dalam persidangan,
kegagalan pengobatan didefinisikan, dan dalam hal bahwa pasien
memiliki kegagalan pengobatan, kode alokasi itu segera dis-
ditutup. Jika pasien dialokasikan untuk kelompok plasebo, mereka
mampu memasukkan dilakukan secara terpisah percobaan rituximab farmakokinetik (RCRNS02) setelah penghentian atau selesainya RCRNS01.