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An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)

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ClinicalTrials.gov Identifier: NCT01269021
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Tracking Information
First Submitted Date  ICMJE December 10, 2010
First Posted Date  ICMJE January 4, 2011
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
the rate of complete remission (CR) at 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2011)
To access the efficacy of MMF compared to corticosteroid in in treatment of proliferative IgAN [ Time Frame: 2 years ]
To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgAN
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • the rate of overall response (CR+ partial remission [PR]) at 6 months [ Time Frame: 6 months ]
  • the median time to CR [ Time Frame: from the start of enrollment to the day of complete remission ]
  • the relapse rate after stopping the treatments [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2011)
To access the safety of MMF compared to corticosteroid in in treatment of proliferative IgAN [ Time Frame: 2 years ]
To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgAN
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)
Official Title  ICMJE Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Brief Summary

In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open, prospective, randomized parallel study to access the efficacy and safety of MMF compared to corticosteroid .

Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the MMF group or corticosteroid group.

Detailed Description To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE IgA Nephropathy (IgAN)
Intervention  ICMJE
  • Drug: mycophenolate mofetil plus lower dose of Prednisone
    MMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d
    Other Name: MMF
  • Drug: Prednisone in full dose
    0.8-1mg/kg/d
Study Arms  ICMJE
  • Experimental: mycophenolate mofetil
    Intervention: Drug: mycophenolate mofetil plus lower dose of Prednisone
  • Active Comparator: Prednisone
    Intervention: Drug: Prednisone in full dose
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 20, 2014)
176
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2011)
50
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients who signed written informed consent form
  2. age between 18-60 years, female or male
  3. diagnosed IgA Nephropathy (IgAN) by renal biopsy during 1 months
  4. renal biopsy had: 10%< crescents<50%; endocapillary hypercellularity; or necrosis ,and interstitial fibrosis<50%,
  5. proteinuria>1g/24h for two times

Exclusion Criteria:

  1. secondary IgA Nephropathy (IgAN);
  2. eGFR<30ml/min/1.73m2.( MDRD formula)
  3. liver disfunction;
  4. uncontrolled hypertension
  5. WBC <3000/mm3
  6. Severe viral infection(HBV, HCV, CMV) within 3 months ofor known HIV infection.
  7. diabetes or obesity(BMI>28) ;
  8. severe infection or central nervous system symptoms.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (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 NCT01269021
Other Study ID Numbers  ICMJE NJCT-1005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhi-Hong Liu, M.D., Nanjing University School of Medicine
Study Sponsor  ICMJE Zhi-Hong Liu, M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhihong Liu, Master Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
PRS Account Nanjing University School of Medicine
Verification Date March 2016

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