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

This study is currently recruiting participants.
Verified March 2013 by Nanjing University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01269021
First received: December 10, 2010
Last updated: March 29, 2013
Last verified: March 2013
History of Changes

December 10, 2010
March 29, 2013
November 2010
May 2013   (final data collection date for primary outcome measure)
To access the efficacy of MMF compared to corticosteroid in in treatment of proliferative IgAN [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgAN
Same as current
Complete list of historical versions of study NCT01269021 on ClinicalTrials.gov Archive Site
To access the safety of MMF compared to corticosteroid in in treatment of proliferative IgAN [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgAN
Same as current
Not Provided
Not Provided
 
An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgAN
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.

In order to treat proliferative 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.

To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgAN.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
IgAN
  • Drug: mycophenolate mofetil
    MMF 1.0-1.5g/d*6mons
    Other Name: MMF
  • Drug: Prednisone
    0.8-1mg/kg/d
  • Experimental: mycophenolate mofetil
    Intervention: Drug: mycophenolate mofetil
  • Active Comparator: Prednisone
    Intervention: Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients who signed written informed consent form
  2. age between 18-60 years, female or male
  3. diagnosed 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 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.
Both
18 Years to 60 Years
No
Contact: Haitao Zhang, Master 0086-025-80860218 haitaozh@yahoo.com.cn
China
 
NCT01269021
NJCT-1005
Yes
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
Zhi-Hong Liu, M.D.
Not Provided
Principal Investigator: Zhihong Liu, Master Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Nanjing University School of Medicine
March 2013

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