A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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