A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome
A Multi-center, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Mizoribine in Comparison With Cyclophosphamide in the Treatment of Refractory Nephrotic Syndrome
1 other identifier
interventional
239
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2014
Typical duration for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJanuary 17, 2019
January 1, 2019
4 years
October 2, 2014
January 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Total Remission rate
52 weeks
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
Mizoribine (MZR)
EXPERIMENTALOral administration, daily dose of 150mg (50mg/tablet, t.i.d) All study subjects will receive standard steroid therapies during the study.
Cyclophosphamide (CTX)
ACTIVE COMPARATORIntravenous 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital)
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital of Nanjing Military Region
Fuzhou, Fujian, China
The first Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Wuxi People's Hospital
Wuxi, Jiangsu, 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 Shenyang Military Region
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
The General Hospital of Jinan Military Region
Jinan, Shandong, China
The Affilited Hospital of Qingdao University
Qingdao, Shandong, China
Renji Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, China
Xinhua Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Kuming General Hospital of Chengdu Military Region
Kunming, Yunnan, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Related Publications (1)
Dong Z, Zhou J, Xu Z, Ni Z, He Y, Lin H, Jiang G, Sun X, Zhang L, Chen X. Efficacy and Safety of Mizoribine for the Treatment of Refractory Nephrotic Syndrome: Protocol for a Multicenter, Controlled, Open-label, Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 16;12:e46101. doi: 10.2196/46101.
PMID: 36990111DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Asahi Kasei Pharma Corporation
Asahi Kasei Pharma Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 6, 2014
Study Start
November 1, 2014
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
January 17, 2019
Record last verified: 2019-01