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Trial record 63 of 1164 for:    MYCOPHENOLIC ACID

Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

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ClinicalTrials.gov Identifier: NCT01895894
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Hee Gyung Kang, 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.


Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Mycophenolate mofetil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Mycophenolate mofetil Drug: Mycophenolate mofetil
Mycophenolate mofetil 20~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)
Other Name: Myrept capsule/tablet

No Intervention: Control



Primary Outcome Measures :
  1. relapse free time [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. adverse effect [ Time Frame: 1 year ]


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Ages Eligible for Study:   2 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895894


Locations
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Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of, 110-740
Sponsors and Collaborators
Seoul National University Hospital
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Hee Gyung Aurea Kang, M.D., Ph.D. Seoul National University Hospital

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Responsible Party: Hee Gyung Kang, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01895894     History of Changes
Other Study ID Numbers: MMF2013
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Hee Gyung Kang, Seoul National University Hospital:
Mycophenolate mofetil
Immunosuppressive Agents
Nephrosis

Additional relevant MeSH terms:
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Mycophenolic Acid
Syndrome
Nephrotic Syndrome
Nephrosis
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action