A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome
- Conditions
- Nephrotic Syndrome
- Interventions
- Registration Number
- NCT02257697
- Lead Sponsor
- Asahi Kasei Pharma Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyclophosphamide (CTX) Cyclophosphamide (CTX) Intravenous injection with between 0.5 to 1.0 g/m2 body surface area each time (the maximum dose is 1.0 g/day each time). All study subjects will receive standard steroid therapies during the study. Mizoribine (MZR) Mizoribine (MZR) Oral administration, daily dose of 150mg (50mg/tablet, t.i.d) All study subjects will receive standard steroid therapies during the study.
- Primary Outcome Measures
Name Time Method Total Remission rate 52 weeks
- Secondary Outcome Measures
Name Time Method Complete Remission rate 52 weeks 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 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 Changes of and percentage change of SCr, eGFR and BUN from the baseline 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks Progression to End-Stage Renal Disease or Doubling of SCr through the study 52 weeks
Trial Locations
- Locations (28)
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Fuzhou General Hospital of Nanjing Military Region
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
The first Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Affiliated Hospital of Guilin Medical University
🇨🇳Guilin, Guangxi, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital)
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The General Hospital of Jinan Military Region
🇨🇳Jinan, Shandong, China
Renji Hospital Shanghai Jiaotong University School of Medical
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital Shanghai Jiaotong University School of Medical
🇨🇳Shanghai, Shanghai, China
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, Shanxi, China
Kuming General Hospital of Chengdu Military Region
🇨🇳Kunming, Yunnan, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The General Hospital of Shenyang Military Region
🇨🇳Shenyang, Liaoning, China
The Affilited Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China