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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02187900
Other study ID # HNXY201401
Secondary ID
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


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
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