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

NCT01269021 | Completed DMC

• 1 other identifier: NJCT-1005
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IgA Nephropathy (IgAN)

Keywords

MMF treatment IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (1)

• the rate of complete remission (CR) at 6 months

  6 months

Secondary Outcomes (3)

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

  6 months

• the median time to CR

  from the start of enrollment to the day of complete remission

• the relapse rate after stopping the treatments

  12 months

Study Arms (2)

mycophenolate mofetil

EXPERIMENTAL

Drug: mycophenolate mofetil plus lower dose of Prednisone

Prednisone

ACTIVE COMPARATOR

Drug: Prednisone in full dose

Interventions

mycophenolate mofetil plus lower dose of Prednisone DRUG

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

Also known as: MMF

mycophenolate mofetil

Prednisone in full dose DRUG

0.8-1mg/kg/d

Prednisone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhi-Hong Liu, M.D.: lead

Study Sites (1)

Research Institute of Nephrology

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Mycophenolic Acid; Prednisone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zhihong Liu, Master

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: January 4, 2011
• Study Start: November 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

CN (1)