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

NCT ID: NCT02257697

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Nephrotic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mizoribine (MZR)

Oral administration, daily dose of 150mg (50mg/tablet, t.i.d) All study subjects will receive standard steroid therapies during the study.

Group Type: EXPERIMENTAL

Mizoribine (MZR)

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide (CTX)

Intervention Type: DRUG

Interventions

Mizoribine (MZR)

Intervention Type: DRUG

Cyclophosphamide (CTX)

Intervention Type: DRUG

Other Intervention Names

HE-69

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asahi Kasei Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asahi Kasei Pharma Corporation

Role: STUDY_CHAIR

Asahi Kasei Pharma Corporation

Locations

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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36990111 (View on PubMed)

Other Identifiers

HE-69-C-Ne-302

Identifier Type: -

Identifier Source: org_study_id