Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.

Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f

The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy.

Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis throughout of the world. The disease is characterized by the predominant deposition of polymer Gal-deficient IgA1 immune complex（pGd-IgA1-IC）in the glomeruli which leads to the proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the treatment of IgAN in Chinese patients, but the price is expensive together with some adverse events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy

Inclusion Criteria:

• urinary protein levels ≥1.0 g/24 h
• estimated glomerular filtration rate (eGFR) ≥30 ml·min-1·1.73 m-2body surface area by the MDRD formula (eGFR=194×age-0.287×serum creatinine
• 1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method, mg/dl))
• peripheral blood white blood cell count ≥3000×109/L
• no other cause for tubulointerstitial lesions
• no history of immunomodulatory agent intake before renal biopsy
• no systemic infection
• age between 16 and 65 years

Exclusion Criteria:

• severe infections