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Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study

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ClinicalTrials.gov Identifier: NCT01185197
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE August 13, 2010
First Posted Date  ICMJE August 19, 2010
Last Update Posted Date June 1, 2018
Study Start Date  ICMJE September 2010
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
Complete remission (24 hour urine protein < 0.3 g) [ Time Frame: at 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01185197 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection [ Time Frame: at 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study
Official Title  ICMJE Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome
Brief Summary Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).
Detailed Description This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nephrosis, Lipoid
Intervention  ICMJE
  • Drug: Myfortic plus low-dose steroid
    Prednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off
    Other Name: Mycophenolate sodium
  • Drug: Prednisolone
    1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician
Study Arms  ICMJE
  • Experimental: Myfortic plus low-dose steroid
    Not necessary
    Intervention: Drug: Myfortic plus low-dose steroid
  • Active Comparator: Standard-dose steroid
    Not necessary
    Intervention: Drug: Prednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female 18 - 65 years of age
  • First histologic diagnosis of MCNS
  • Proteinuria > 3.5 g/day
  • Patients who are willing to give written, informed consent

Exclusion Criteria:

  • Presence of secondary causes of MCNS
  • History of glomerular disease including MCNS
  • eGFR < 50 ml/min/1.73m2
  • Renal histology showing pathologies other than MCNS
  • Female of child-bearing age who are unwilling to practice effective contraception
  • Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01185197
Other Study ID Numbers  ICMJE Novartis-ST-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sydney CW Tang, MD, PhD The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP