Lupus Nephritis
Conditions
Brief summary
To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.
Interventions
Sponsors
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient has been diagnosed with SLE according to American College of Rheumatology (ACR) criteria in 1997; * Patient who has had a kidney biopsy within 365 days prior to screening which was confirmed as class III, III+V, IV, IV+V, or V according to the pathologic classification of International Society of Nephrology/Renal Pathology Society (ISN/RPS) in 2003; * Patient with 24hr-urine protein ≥ 1.0g; * SLE-DAI \> 8 ; * Male or female patient between 18 and 70 years (inclusive) at informed consent obtained date; * Patient with body weight between 40kg and 80kg (inclusive) at screening; * Patients who sign the informed consent form;
Exclusion criteria
* Patient who had history of allergy to any investigational product (MZR, CTX) or hormone; * Patient who had received accumulated dosage of CTX \>3g within one year prior to screening. * Patient who had received immunosuppressant or Chinese traditional medicine with immunosuppressive effect within 30 days prior to screening; * Patient who had received prednisone\>1.0mg/kg/day or equivalent dose of other oral glucocorticoid therapies within 30 days prior to screening; * Patient who received other investigational drugs within 30 days prior to screening; * Patient who have received plasma exchange therapy or immunoadsorption therapy within 30 days prior to screening; * Patient who require pentostatin or live vaccine (not including flu vaccine); * Patient who is undergoing renal replacement therapy; * Patient who received kidney transplantation; * Patient with malignancy; * Patient with severe hypertension (SBP \> 160mmHg or DBP \> 100mmHg) which has not been effectively controlled; * Patient with white blood cell count \<3×109/L /L(=3.0 GI/L); * Patient with SCr \> 176.8μmol/L; * Patient who has a value that is \> 3 times of the upper limit of normal range for AST or ALT; * Patient with hepatitis B, hepatitis C or HIV infection; * Patient with other serious infections; * Patient who is unsuitable for participating in this study in the opinion of investigators ( e.g. uncontrolled diabetes, central nervous system lupus , lupus encephalopathy, active psychosis,osteonecrosis of the femoral head, fulminant hepatitis, peptic ulcer, etc.); * Female patient who is pregnant, currently breast feeding or willing to become pregnant; * Patient with any other diseases that would affect the evaluation of efficacy or safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Remission rate | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Partial Remission rate | 52 weeks |
| Changes of Overall Remission rate | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Changes of Complete Remission rate | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Changes of partial remission rate | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Treatment failure rate | 52 weeks |
| Complete Remission rate | 52 weeks |
| Changes of and percentage change of SCr, eGFR and BUN from the baseline | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
| Changes of immunological test (C3, Anti-DNA antibody, ANA, Anti-Sm antibody and Anti-phospholipid antibody) from baseline | 20 weeks and 52 weeks |
| Changes of SLE-DAI score from baseline | 20 weeks and 52 weeks |
| Progression to End-Stage Renal Disease or Doubling of SCr through the study. | 52 weeks |
| Changes and percentage change of 24 hours urine protein and serum albumin from the baseline | 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks |
Countries
China
Outcome results
None listed