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

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02187900
• Other study ID #: HNXY201401
• Status: Recruiting
• Phase: Phase 3
• First received: June 22, 2014
• Last updated: July 10, 2014
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2014
• Source: Second Xiangya Hospital of Central South University
• Contact: Youming Peng, M.D
• Phone: 8615802604114
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy

Intervention

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.
• Mycophenolate mofetil (MMF)
Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months

Locations

Country	Name	City	State
China	The second Xiangya Hospital of CSU	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse event	liver function test result abnormalities;menstrual disturbance	one year	Yes
Primary	Number of patients reaching remission	(i) complete remission was de?ned 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 de?ned 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 de?ned 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	one year	No
Secondary	Renal survival	Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.	one year	Yes