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Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial

Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial - Cyclosporine C2 monitaring: A randomized controlled trial(JSKDC03)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000008
Enrollment
100
Registered
2005-08-01
Start date
2005-04-01
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 C2 monitoring with higher target levels Cyclosporine C2 monitoring by lower target levels

Sponsors

Japanese Study Group of Kidney Disease in Children
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Primary nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL). 2.Frequently relapse or steroid independence, based on the International study of kidney disease in children. 3.Biopsy diagnoses of MCNS, MPGN or FSGS, where a renal biopsy has been performed within 12 months before eligibility. 4.Aged twelve months to 18 years. 5.Written informed consent from the patients' parents or legal guardians.

Exclusion criteria

Exclusion criteria: 1.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 2.History of steroid resistance. 3.Medical history of allergy or hypersensitivity reactions to cyclosporine. 4.Poorly controlled hypertension. 5.Chronic renal dysfunction. 6.Active infectious disease. 7.Severe liver disfunction. 8.History of cyclosporine administration. 9.Pregnancy. 10.Judged inappropriate for this study by the physicians.

Design outcomes

Primary

MeasureTime frame
Relapse-free rate

Countries

Japan

Contacts

Public ContactNakanishi

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