Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome
Lead Sponsor:
Asahi Kasei Pharma Corporation
Conditions:
Nephrotic Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To demonstrate that the treatment effect in refractory nephrotic syndrome of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.
Eligibility Criteria
Inclusion
- Patients who have medical history with clear documentation of diagnosis of nephrotic syndrome
- Patient who received renal biopsy within 1 year prior to screening and confirmed the pathologic classification: Minimal Change Disease (MCD), IgA nephropathy, Mesangioproliferative Glomerulonephritis (MsPGN), Membranous Nephropathy (MN), Focal Segmental Glomerulosclerosis (FSGS)
- Patient with the above different pathologic classification who received adequate hormone therapy more than 8 weeks (including FSGS more than 12 weeks)prior to screening and have 24hr-urine protein≥2.0g/day at screening Adequate hormone dose is defined as prednisone (prednisolone) equivalent dose of 0.8 to 1.0 mg/kg/day (inclusive)
- 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
- Other primary nephrotic syndrome, e.g. membrano-proliferative glomerulonephritis (MPGN)
- Secondary nephrotic syndrome (e.g. diabetic nephropathy, anaphylactic purpura nephritis, lupus nephritis, type B hepatitis-related nephritis, renal amyloidosis)
- 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 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 :
November 1 2018
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT02257697
Start Date
November 1 2014
End Date
November 1 2018
Last Update
January 17 2019
Active Locations (28)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
2
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
3
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
4
Chinese PLA General Hospital
Beijing, Beijing Municipality, China