Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis
Lead Sponsor:
Asahi Kasei Pharma Corporation
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT02256150
Start Date
November 1 2014
End Date
March 1 2019
Last Update
June 7 2019
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
3
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
4
Peking University People's Hospital
Beijing, Beijing Municipality, China