To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy

Laborértékek

• • Secondary IgA nephropathy such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B-associated nephritis, etc.
  • IgA nephropathy with significant glomerulosclerosis or cortical scarring.
  • Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement criteria.
  • Rapidly progressive nephritic syndrome.
  • Acute renal failure, including rapidly progressive IgA nephropathy.
  • Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
  • Cirrhosis, chronic active liver disease, and serious liver function damage.
  • 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 or untreated latent TB infection.
  • 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.
  • Any condition, including any uncontrolled disease state other than IgA nephropathy.

• Age 18~75 years, regardless of gender.
• Clinical evaluation and renal biopsy diagnostic for IgA nephropathy.
• Average urinary protein excretion of 0.3~3.5g/24h on two successive examinations.
• Urine Protein to Creatinine Ratio (UPCR) >= 0.75 and <= 6 milligram per milligram (mg/mg) during screening.
• Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening.
• eGFR≥30 ml/min/1.73m2.
• Willingness to sign an informed consent.