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:
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: August 20, 2014
Last verified: August 2014
  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: 6 months ] [ 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: 6 months ] [ Designated as safety issue: Yes ]
    To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN)


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
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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: August 20, 2014
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
Autoimmune Diseases
Glomerulonephritis
Immune System Diseases
Nephritis
Urologic Diseases
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014