A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asahi Kasei Pharma Corporation
• Treatments: Bredinin; Cyclophosphamide; Mizoribine

Criteria

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.