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NCT Number: NCT01269021

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

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.

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Key information

Conditions

IgA Nephropathy (IgAN) Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Nephrology

Nanjing, Jiangsu, 210002, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • secondary IgA Nephropathy (IgAN);
  • eGFR<30ml/min/1.73m2.( MDRD formula)
  • liver disfunction;
  • uncontrolled hypertension
  • WBC <3000/mm3
  • Severe viral infection(HBV, HCV, CMV) within 3 months ofor known HIV infection.
  • diabetes or obesity(BMI>28) ;
  • severe infection or central nervous system symptoms.

Treatment and study plan

mycophenolate mofetil plus lower dose of Prednisone

Drug

MMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d

Other names: MMF

Prednisone in full dose

Drug

0.8-1mg/kg/d

Primary outcomes

  1. the rate of complete remission (CR) at 6 months

    Time frame: 6 months

Secondary outcomes

  1. the rate of overall response (CR+ partial remission [PR]) at 6 months

    Time frame: 6 months

  2. the median time to CR

    Time frame: from the start of enrollment to the day of complete remission

  3. the relapse rate after stopping the treatments

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Zhi-Hong Liu, M.D.

Other

Registry information

Official study title

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jan 4, 2011
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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