Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

Phase 4

Completed

• Conditions: Nephrotic Syndrome
• Interventions: Drug: Mycophenolate mofetil

• Registration Number: NCT01895894
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.

Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-07
• Study First Submitted QC: 2013-07-07
• Study First Posted: 2013-07-11
• Study Start: 2013-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year
• in complete remission

Exclusion Criteria

• Hereditary or secondary nephrotic syndrome
• Estimated glomerular filtration rate (GFR) < 60 mg/min/1.73 m^2
• Body weight <16 kg
• leukocytopenia (absolute neutrophil count < 2000/mm^3) or anemia(Hct < 25%)
• Severe gastrointestinal disease
• chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
• prior live vaccine inoculation within 6 weeks (from the study enrollment)
• GOT/GPT elevation or hyperbilirubinemia
• malignant disease
• Pregnant or Breast feeding
• Previous history of mycophenolate mofetil use
• Participation to other therapeutic trial within recent 3 months
• Deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycophenolate mofetil	Mycophenolate mofetil	-

Primary Outcome Measures

Name	Time	Method
relapse free time	1 year

Secondary Outcome Measures

Name	Time	Method
adverse effect	1 year

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of