NCT02187900

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)	The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
DRUG	Mycophenolate mofetil (MMF)	Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2014-07-11
• Last updated: 2014-07-11

Locations

1 site across 1 country: China