Status:
COMPLETED
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)
Lead Sponsor:
Sun Yat-sen University
Conditions:
IgA Nephropathy
Eligibility:
All Genders
14-60 years
Phase:
PHASE3
Brief Summary
A multi-center, randomized, controlled clinical trial to evaluate the short-term and long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and preserving renal function ...
Detailed Description
There are four phases of study for each subject. Phase 1 the screening phase. During this phase each potential subject will be evaluated to determine if he/she is eligible for the study. Phase 2 the ...
Eligibility Criteria
Inclusion
- Willingness to sign an informed consent
- Age:14\~60 years, regardless of gender
- Clinical evaluation and renal biopsy diagnostic for IgAN, excluded secondary IgAN. Renal histological criteria should be defined by Lee's glomerular grading system.
- 1 g/day \<= proteinuria \< 3.5 g/day, or UPr/Cr ratio ≥ 0.6 (male) or ≥ 0.8 (female) when taking ARB
- eGFR ≥ 40 mL/min/1.73 m2
Exclusion
- Inability or unwillingness to sign the informed consent
- Inability or unwillingness to meet the scheme demands raised by the investigators
- Rapidly progressive nephritic syndrome and acute renal failure, including rapidly progressive IgAN ( IgAN with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents.
- Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis
- est GFR \< 40 mL/min/1.73m2
- Malignant hypertension that is difficult to be controlled by oral drugs
- Cirrhosis, chronic active liver disease.
- History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease.)
- Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C.
- Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)
- Malignant tumors (except fully cured basal cell carcinoma)
- Absolute neutrophil count \< 1500／mm3, absolute platelet count \<75000／mm3 or hematocrit (Hct) \<28% (anemic subjects may be reevaluated after the anemia has been treated.)
- Known allergy, contraindication or intolerance to the MMF, corticosteroids or ACEI/ARB.
- Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception
- Current exposure to MMF or azathioprine. In case of current treatment with oral steroid or ACEI/ARB, entry is permitted after corticosteroids or ACEI/ARB are stopped for 2 weeks.
- Current or recent (within 30 days) exposure to any other investigational drugs
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00657059
Start Date
September 1 2007
End Date
May 1 2019
Last Update
December 3 2019
Active Locations (1)
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1
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, China, 510080