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Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

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Seoul National University

Status and phase

Completed
Phase 4

Conditions

Nephrotic Syndrome

Treatments

Drug: Mycophenolate mofetil

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01895894
MMF2013

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

2 to 24 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Mycophenolate mofetil
Experimental group
Treatment:
Drug: Mycophenolate mofetil
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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