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

January 15, 2019 updated by: Asahi Kasei Pharma Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • China-Japan Friendship Hospital
      • Beijing, Beijing, China
        • Chinese PLA General Hospital
      • Beijing, Beijing, China
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing, China
        • Beijing Tongren Hospital, Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China
        • The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital)
    • Fujian
      • Fuzhou, Fujian, China
        • The First Affiliated Hospital of Fujian Medical University
      • Fuzhou, Fujian, China
        • Fuzhou General Hospital of Nanjing Military Region
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital, Sun Yat-sen University
    • Guangxi
      • Guilin, Guangxi, China
        • Affiliated Hospital of Guilin Medical University
      • Nanning, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
    • Hebei
      • Shijiazhuang, Hebei, China
        • The Third Hospital of Hebei Medical University
    • Jiangsu
      • Wuxi, Jiangsu, China
        • Wuxi People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China
        • The First hospital of Jilin University
      • Changchun, Jilin, China
        • the Second Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China
        • The First Affiliated Hospital of Dalian Medical University
      • Shenyang, Liaoning, China
        • The General Hospital Of Shenyang Military Region
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Hospital
      • Jinan, Shandong, China
        • The General Hospital of Jinan Military Region
      • Qingdao, Shandong, China
        • The Affilited Hospital of Qingdao University
    • Shanghai
      • Shanghai, Shanghai, China
        • Zhongshan Hospital Fudan University
      • Shanghai, Shanghai, China
        • Renji Hospital Shanghai Jiaotong University School of Medical
      • Shanghai, Shanghai, China
        • Xinhua Hospital Shanghai Jiaotong University School of Medical
    • Shanxi
      • Taiyuan, Shanxi, China
        • The Second Hospital of Shanxi Medical University
      • Xian, Shanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University
    • Yunnan
      • Kunming, Yunnan, China
        • Kuming General Hospital of Chengdu Military Region
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of College of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mizoribine (MZR)
Oral administration, daily dose of 150mg (50mg/tablet, t.i.d) All study subjects will receive standard steroid therapies during the study.
Drug: Mizoribine (MZR)
Other Names:
  • HE-69
Active Comparator: 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.
Drug: Cyclophosphamide (CTX)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total Remission rate
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Complete Remission rate
Time Frame: 52 weeks
52 weeks
Partial Remission rate
Time Frame: 52 weeks
52 weeks
Changes of Overall Remission rate
Time Frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Changes of Complete Remission rate
Time Frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Changes of Partial Remission rate
Time Frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Treatment failure rate
Time Frame: 52 weeks
52 weeks
Changes and percentage change of 24 hours urine protein and serum albumin from the baseline
Time Frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Changes of and percentage change of SCr, eGFR and BUN from the baseline
Time Frame: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks
Progression to End-Stage Renal Disease or Doubling of SCr through the study
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asahi Kasei Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HE-69-C-Ne-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings