A multi-center randomized controlled trial of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)

A multi-center randomized controlled trial of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06) - A RCT of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004204

Enrollment

120

Registered

2010-10-01

Start date

2010-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frequently relapsing nephrotic syndrome in children

Interventions

Cyclosporine for 2 years Tacrolimus for 2 years

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Relapse-free time	—

Countries

Japan

Contacts

Public ContactYuko Shima

Japanese Study Group of Kidney Disease in Children Department of Pediatrics, Wakayama Medical University

jskdc@wakayama-med.ac.jp073-441-0633

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026