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

Phase 3

• Conditions: IgA Nephropathy
• Interventions: Drug: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH); Drug: Mycophenolate mofetil (MMF)

• Registration Number: NCT02187900
• Lead Sponsor: Second Xiangya Hospital of Central South University

Brief 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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-22
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-10
• Last Update Submitted: 2014-07-10
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11
• Primary Completion: 2015-08
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TWH for the treatment of IgAN	Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)	Interventions :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.
MMF for IgAN	Mycophenolate mofetil (MMF)	MMF for the treatment of IgAN for 6 months

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Renal survival	one year	Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.

Trial Locations

Locations (1)

The second Xiangya Hospital of CSU; 🇨🇳 Changsha, Hunan, China