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

This study is currently recruiting participants.
Verified June 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: June 7, 2013
Last verified: June 2013
  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
Drug: Prednisone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Nanjing University School of Medicine:

Primary Outcome Measures:
  • To access the efficacy of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To access the efficacy and safety of MMF compared to corticosteroid in treatment of proliferative IgA Nephropathy(IgAN)


Secondary Outcome Measures:
  • To access the safety of MMF compared to corticosteroid in treatment of proliferative IgA Nephropathy(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 IgA Nephropathy(IgAN)


Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mycophenolate mofetil Drug: mycophenolate mofetil
MMF 1.0-1.5g/d*6mons
Other Name: MMF
Active Comparator: Prednisone Drug: Prednisone
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269021

Contacts
Contact: Haitao Zhang, Master 0086-025-80860218 haitaozh@yahoo.com.cn

Locations
China, Jiangsu
Research Institute of Nephrology Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Haitao Zhang, Master    0086-025-80860218    haitaozh@yahoo.com.cn   
Contact: Weibo Le, Master    0086-025-80860218 ext 210002    leweibo@gmail.com   
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

No publications provided

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
Study First Received: December 10, 2010
Last Updated: June 7, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
MMF treatment IgA Nephropathy (IgAN)

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 22, 2014