Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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 in patients with IgAN who have pre-treated (and continue to be treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Irbesartan; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

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 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 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