Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:

A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895894
• Other study ID #: MMF2013
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2013
• Last updated: July 4, 2017
• Start date: September 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

Drug:
• Mycophenolate mofetil
Mycophenolate mofetil 20~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse free time		1 year
Secondary	adverse effect		1 year