lupus nephritis
Conditions
Interventions
TAC group:Tacrolimus (0.04-0.08 mg/kg/d) and prednisone for 12 months
CYC group:cyclophosphamide (750mg/m2 per month for six months) and prednisone followed by azathioprine (50mg/day) for 6 months
Sponsors
the First Affiliated Hospital,College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
15 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 70 years old; 2. Able and willing to provide signed informed consent; 3. Patients with SLE; 4. lupus nephritis IV, V, IV+V, IV+III; 5. urinary protein excretion of at least 2.0 g per 24 h; 6. serum creatinine less than 221 umol/l (2.5mg/dl); 7. cretinine clearance more than 30 ml/min/1.73m2.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating; 2. Previous treatment with cyclosporine, mycophenolate mofetil treatment for at least two weeks in the previous three months; 3. Known allergies to calcineurin inhibitors; 4. Severe infection; 5. Alanine aminotransferase more than 100U/l or evidence of active hepatitis; 6. Fasting blood glucose more than 6.2 mmol/l and/or 2 h post-meal blood glucose more than 11.1mmol/l.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLE-DAI values;cretinine clearance;anti-ds-DNA;serum C3 levels;mean serum albumin level;serum creatinine;mean urinary protein excretion;serious pulmonary infection; | — |
Countries
China
Contacts
Public ContactJianghua Chen
Outcome results
None listed