Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

NCT ID: NCT01895894

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Nephrotic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mycophenolate mofetil

Group Type: EXPERIMENTAL

Mycophenolate mofetil

Intervention Type: DRUG

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mycophenolate mofetil

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

Intervention Type: DRUG

Other Intervention Names

Myrept capsule/tablet

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee Gyung Kang

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee Gyung Aurea Kang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Children's Hospital

Seoul, , South Korea

Countries

South Korea

References

Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

Reference Type: DERIVED

PMID: 39513526 (View on PubMed)

Other Identifiers

MMF2013

Identifier Type: -

Identifier Source: org_study_id