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

IgA Nephropathy (IgAN) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269021
• Other study ID #: NJCT-1005
• Status: Completed
• Phase: N/A
• First received: December 10, 2010
• Last updated: March 15, 2016
• Start date: November 2010
• Est. completion date: April 2014

Study information

• Verified date: March 2016
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy (IgAN)
• Kidney Diseases

Intervention

Drug:
• mycophenolate mofetil plus lower dose of Prednisone
MMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d
• Prednisone in full dose
0.8-1mg/kg/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhi-Hong Liu, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of complete remission (CR) at 6 months		6 months	Yes
Secondary	the rate of overall response (CR+ partial remission [PR]) at 6 months		6 months	Yes
Secondary	the median time to CR		from the start of enrollment to the day of complete remission	Yes
Secondary	the relapse rate after stopping the treatments		12 months	Yes