A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age 14~65 years, regardless of gender

• Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus.

• Average urinary protein excretion of 0.5~3.5g/24h on two successive examinations.

• eGFR ≥ 50 ml/min/1.73 m2

• Willingness to sign an informed consent.

Exclusion Criteria:

• Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.

• Rapidly progressive nephritic syndrome (crescent formation≥50%).

• Acute renal failure, including rapidly progressive IgAN.

• Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).

• Date of renal biopsy exceeds more than 30 days.

• 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.

• 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).

• Active tuberculosis

• Malignant hypertension that is difficult to be controlled by oral drugs.

• Known allergy, contraindication or intolerance to the steroids.

• Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.

• Malignant tumors

• Excessive drinking or drug abuse

• Mental aberrations

• Current or recent (within 30 days) exposure to any other investigational drugs.