IgA Nephropathy
Conditions
Keywords
Tripterygium Wilfordii HOOK. f., Mycophenolate mofetil
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
Interventions
DRUGMulti-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.
DRUGMycophenolate mofetil (MMF)
Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Renal survival | one year | Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration. |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse event | one year | liver function test result abnormalities;menstrual disturbance |
Countries
China
Contacts
Primary ContactYouming Peng, M.D
Outcome results
None listed