Phase
Condition
Glomerulonephritis
Kidney Disease
Nephropathy
Treatment
N/AClinical Study ID
Ages 14-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
Exclusion Criteria:
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 rapidlyprogressive IgAN ( IgAN with rapid decline in renal function characterizedhistologically by necrotizing vasculitis and crescent formation≥30%) necessitating theuse of other immunosuppressive agents.
Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuricnephritis 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 oractive peptic ulcer disease.)
Any Active systemic infection or history of serious infection within one month ofentry or known infection with HIV, hepatitis B, or hepatitis C.
Other major organ system disease (e.g. serious cardiovascular diseases includingcongestive heart failure , chronic obstructive pulmonary disease, asthma requiringoral 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 orACEI/ARB.
Pregnancy or breast feeding at the time of entry or unwillingness to comply withmeasures for contraception
Current exposure to MMF or azathioprine. In case of current treatment with oralsteroid or ACEI/ARB, entry is permitted after corticosteroids or ACEI/ARB are stoppedfor 2 weeks.
Current or recent (within 30 days) exposure to any other investigational drugs
Study Design
Study Description
Connect with a study center
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available

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