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Nephrotic SyndromePhase 3NCT02257697

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

A Phase 3 study testing Mizoribine (MZR) and Cyclophosphamide (CTX) in people with Nephrotic Syndrome, run by Asahi Kasei Therapeutics Corporation at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nephrotic Syndrome
What is being tested?
Mizoribine (MZR) and Cyclophosphamide (CTX)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
28 sitesChina
Study dates
Nov 2014to Nov 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital)

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Fuzhou General Hospital of Nanjing Military Region

    Fuzhou, Fujian

  • The first Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • Shandong Provincial Hospital

    Jinan, Shandong

  • The General Hospital of Jinan Military Region

    Jinan, Shandong

  • Kuming General Hospital of Chengdu Military Region

    Kunming, Yunnan

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • The Affilited Hospital of Qingdao University

    Qingdao, Shandong

  • Renji Hospital Shanghai Jiaotong University School of Medical

    Shanghai, Shanghai Municipality

  • Xinhua Hospital Shanghai Jiaotong University School of Medical

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality

  • The General Hospital of Shenyang Military Region

    Shenyang, Liaoning

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Wuxi People's Hospital

    Wuxi, Jiangsu

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi

Other trials in China

About this study

Official title: 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.

Being tested
Mizoribine (MZR), Cyclophosphamide (CTX)
Medical subject headings
Nephrotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mizoribine (MZR)Drug

    Also called HE-69

  • Cyclophosphamide (CTX)Drug

Study groups in NCT02257697
Study groupRoleWhat they receive
Mizoribine (MZR)ExperimentalOral administration, daily dose of 150mg (50mg/tablet, t.i.d) All study subjects will receive standard steroid therapies during the study.
Receives: Drug: Mizoribine (MZR)
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.
Receives: Drug: Cyclophosphamide (CTX)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Remission rate

    Measured: 52 weeks

Secondary outcomes (9)

  1. Complete Remission rate

    Measured: 52 weeks

  2. Partial Remission rate

    Measured: 52 weeks

  3. Changes of Overall Remission rate

    Measured: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks

  4. Changes of Complete Remission rate

    Measured: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks

  5. Changes of Partial Remission rate

    Measured: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks

  6. Treatment failure rate

    Measured: 52 weeks

  7. Changes and percentage change of 24 hours urine protein and serum albumin from the baseline

    Measured: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks

  8. Changes of and percentage change of SCr, eGFR and BUN from the baseline

    Measured: 8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks

  9. Progression to End-Stage Renal Disease or Doubling of SCr through the study

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionNov 2018
  4. Study completionNov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02257697
Sponsor's protocol ID
HE-69-C-Ne-302
Status last verified
Jan 2019
First submitted
2 Oct 2014
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36990111

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mizoribine (MZR) and Cyclophosphamide (CTX) in people with Nephrotic Syndrome, run by Asahi Kasei Therapeutics Corporation at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Remission rate (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02257697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.

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