A RCT of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)

Phase 3

• Conditions: Frequently relapsing nephrotic syndrome in children

• Registration Number: JPRN-jRCTs031180132
• Lead Sponsor: Kamei Koichi

Brief Summary

on-inferiority of the tacrolimus treatment course to the cyclosporine treatment course was not tested.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-18
• Study Completion: 2021-03-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

(1)The initial episode of idiopathic nephrotic syndrome
(2)Treated with predonisolone therapy based on the International study of kidney disease
(3)Aged two years under 18 years
(4)Diagnosis of FRNS has been performed within 3 months before eligibility
(5)Diagnosis of steroid sensitive NS has been performed within the third week after the onset of PSL treatment
(6)Patient will be able to go to hospital during therapy
(7)Written informed consent from the patients' parents or legal guardians

Exclusion Criteria

(1)Other renal nephrotic syndrome (IgA nephropathy)
(2)History of Henoch-Schounlein nephritis, systemic lupus erythematosus or secondary nephrotic syndrome
(3)History of steroid resistant NS
(4)Prior treatment of cyclosporine or tacrolimus
(5)History of immunosuppressants administration against nephrotic syndrome within one month before eligibility
(6)History of allergy or hypersensitivity reactions to cyclosporine or tacrolimus
(7)Either father or mother has diagnosed with diabetes mellitus
(8)Fasting blood glucose level more than 110 mg/dL/casual blood glucose level more than 200 mg/dL or HbA1c(NSGP) more than 6.4%, History of diabetes mellitus that needs medical attention administration
(9)Body Mass Index more than 30
(10)Uncontrollable hypertension
(11)Renal dysfunction (creatinine clearance < 60 mL/min)
(12)Severe liver dysfunction
(13)Active infectious disease
(14)Women during pregnancy or who wish pregnancy during therapy
(15)Patients enrolling another clinical trials
(16)Judged inappropriate for this study by the physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse-free survival

Secondary Outcome Measures

Name	Time	Method
Progression to FRNS-free survival