Status:
COMPLETED
Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Chong Kun Dang Pharmaceutical
Conditions:
Nephrotic Syndrome
Eligibility:
All Genders
2-24 years
Phase:
PHASE4
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 ad...
Eligibility Criteria
Inclusion
- Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year
- in complete remission
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01895894
Start Date
September 1 2013
End Date
December 1 2016
Last Update
July 6 2017
Active Locations (1)
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1
Seoul National University Children's Hospital
Seoul, South Korea, 110-740