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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269021
First Posted: January 4, 2011
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
  Purpose

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.


Condition Intervention
IgA Nephropathy (IgAN) Drug: mycophenolate mofetil plus lower dose of Prednisone Drug: Prednisone in full dose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.

Resource links provided by NLM:


Further study details as provided by Zhi-Hong Liu, M.D., Nanjing University School of Medicine:

Primary Outcome Measures:
  • the rate of complete remission (CR) at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 176
Study Start Date: November 2010
Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mycophenolate mofetil 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
Active Comparator: Prednisone Drug: Prednisone in full dose
0.8-1mg/kg/d

Detailed Description:
To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT01269021


Locations
China, Jiangsu
Research Institute of Nephrology
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Zhi-Hong Liu, M.D.
Investigators
Principal Investigator: Zhihong Liu, Master Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
  More Information

Responsible Party: Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01269021     History of Changes
Other Study ID Numbers: NJCT-1005
First Submitted: December 10, 2010
First Posted: January 4, 2011
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Zhi-Hong Liu, M.D., Nanjing University School of Medicine:
MMF treatment IgA Nephropathy (IgAN)

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Prednisone
Mycophenolic Acid
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action