Lupus nephritis
Conditions
Interventions
The experimental group:Kunxian Capsule (0.6g bid po) + Glucocorticoid (equal to less than 10mg/d prednisone)
Control group:Mycophenloate Mofetil Tablets (0.5g bid po) + Glucocorticoid (equal to less than 10mg/d prednisone)
Sponsors
Department of rheumatology, Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients had a history of SLE according to 2009 ACR criteria and had either class III or class IV lupus nephritis by the ISN/RPS classification system; 2. Patients achieves partial remission after intravenous CTX induced treatment (partial remission: a. the 24 h urine protein improve =50% by the baseline level and between 0.3 g/d to 2.9 g/d, b. Serum albumin =30 g/L, c. Serum creatinine increased =25%. The accumulated dose of CTX is less than 6 gram and the cumulative time is 6 months or less (in the last 12-18 months); 3. Patients with low-dose oral corticosteroids (maximum dose, 10 mg per day); 4. Patients between 18 to 75 years old (no need for fertility in the later 5 years); 5. Patients with stable doses of hydroxychloroquine, angiotensin I converting enzyme inhibitor/angiotensin II receptor blockers, but the doses should be stable at least 4 weeks and needs to keep constant during the study.
Exclusion criteria
Exclusion criteria: 1. Patients do not meet the inclusion criteria above; 2. Patients with other rheumatic immune diseases; 3. Patients combined with severe primary or secondary diseases of other systems; 4. Pregnant and lactating women or patients with requirement for fertility; 5. Patients allergic to the experimental drugs; 6. Patients have been using biological agents within 3 months; 7. Patients with abnormal baseline laboratory results, or serum albumin <20 g/L; 8. Patients who are participating in another clinical trial within 1 month. Unable to provide informed consent; 9. Patients who plan to receive renal transplantation in the later half year; 10. Patients who have not signed the informed consent or are unsuitable for this clinical trial considered by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24h urine protein quantification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine analysis + urine sediment;Full remission rate/reburning rate;C3;C4;dsDNA;Serum albumin content;SLEDAI;BILAG;VAS;HAQ;EQ5D;ESR;CRP;autoimmune antibody 17 items; | — |
Countries
China
Contacts
Public ContactHuang Qingchun/Huang Runyue
Department of rheumatology, Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed