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

JRCT ID: jRCTs031180132

Registered date:18/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Frequently relapsing nephrotic syndrome in children
• Date of first enrollment: 27/12/2010
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Treatment

Outcome(s)

• Primary Outcome: Relapse-free survival
• Secondary Outcome: Progression to FRNS-free survival

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: < 18age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kamei Koichi
• Secondary ID(s): UMIN000004204