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

NCT02187900 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Second Xiangya Hospital of Central South University
Phase	Phase 3
Status	UNKNOWN
Enrolment	300
Start date	2014-06
Completion	2015-09

Conditions

• IgA Nephropathy

Interventions

• Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
• Mycophenolate mofetil (MMF)

Primary outcomes

• Number of patients reaching remission — one year
  (i) complete remission was defined as the absence of proteinuria (24-h urine protein \< 0.4 g/24 h), serum albumin \>35 g/L and Scr \< 1.24 mg/ dL; (ii) partial remission was defined as a 24-h urine protein ≤ 3.5 g/24 h and a decline of \>50% of the baseline value with an Scr elevation of \<15% of the baseline value; (iii) no response was defined as a 24-h urine protein \>3.5 g/24h, or a decline \< 50% of base- line value or increase and/or an Scr level \>50% of the baseline value

Countries

China