- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02256150
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis
June 5, 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 Lupus Nephritis
To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- 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
-
-
Beijing
-
Beijing, Beijing, China
- China-Japan Friendship Hospital
-
Beijing, Beijing, China
- Chinese Pla General Hospital
-
Beijing, Beijing, China
- Peking University People's Hospital
-
Beijing, Beijing, China
- Beijing Friendship 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
-
-
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
-
-
Henan
-
Zhengzhou, Henan, China
- The First Affiliated hospital of Zhengzhou University
-
-
Hubei
-
Wuhan, Hubei, China
- Zhongnan Hospital of Wuhan University
-
Wuhan, Hubei, China
- Renmin Hospital of Wuhan University
-
-
Jiangsu
-
Wuxi, Jiangsu, China
- Wuxi People's Hospital
-
-
Jilin
-
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
-
-
Shanxi
-
Taiyuan, Shanxi, China
- The Second Hospital of Shanxi Medical University
-
Xian, Shanxi, China
- The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
-
-
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
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient has been diagnosed with SLE according to American College of Rheumatology (ACR) criteria in 1997;
- Patient who has had a kidney biopsy within 365 days prior to screening which was confirmed as class III, III+V, IV, IV+V, or V according to the pathologic classification of International Society of Nephrology/Renal Pathology Society (ISN/RPS) in 2003;
- Patient with 24hr-urine protein ≥ 1.0g;
- SLE-DAI > 8 ;
- 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:
- 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 had received prednisone>1.0mg/kg/day or equivalent dose of other oral glucocorticoid therapies 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 |
Intervention / Treatment |
---|---|
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.
|
Other Names:
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Remission rate
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
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
|
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
|
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
|
Changes of immunological test (C3, Anti-DNA antibody, ANA, Anti-Sm antibody and Anti-phospholipid antibody) from baseline
Time Frame: 20 weeks and 52 weeks
|
20 weeks and 52 weeks
|
Changes of SLE-DAI score from baseline
Time Frame: 20 weeks and 52 weeks
|
20 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
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
November 1, 2014
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
October 1, 2014
First Submitted That Met QC Criteria
October 1, 2014
First Posted (Estimate)
October 3, 2014
Study Record Updates
Last Update Posted (Actual)
June 7, 2019
Last Update Submitted That Met QC Criteria
June 5, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Connective Tissue Diseases
- Glomerulonephritis
- Lupus Erythematosus, Systemic
- Nephritis
- Lupus Nephritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Cyclophosphamide
- Mizoribine
Other Study ID Numbers
- HE-69-C-Lu-301
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.
Clinical Trials on Lupus Nephritis
-
Imperial College LondonKarolinska Institutet; Ohio State University; Dutch Working Party on Systemic... and other collaboratorsTerminatedSystemic Lupus Erythematosus, Lupus NephritisUnited Kingdom
-
Sun Yat-sen UniversityCompleted
-
Peking UniversityCompleted
-
University Hospital, GrenobleInstitut de Biologie Structurale GrenobleCompletedSystemic Lupus Erythematosus NephritisFrance
-
Peking Union Medical College HospitalUnknownNephritis, LupusChina
-
Artiva Biotherapeutics, Inc.RecruitingLupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class IIIUnited States
-
Kyverna TherapeuticsRecruitingLupus Nephritis | Lupus Nephritis - WHO Class IV | Lupus Nephritis - WHO Class IIIGermany
-
Minia UniversityNot yet recruitingmfERG in Lupus NephritisEgypt
-
Kyverna TherapeuticsRecruitingLupus Nephritis | Lupus Nephritis - World Health Organization (WHO) Class III | Lupus Nephritis - WHO Class IVUnited States
-
Centre Hospitalier Universitaire, AmiensCompletedLupus Nephritis | Systemic Lupus Erythematosus (SLE)France
Clinical Trials on Cyclophosphamide (CTX)
-
Masonic Cancer Center, University of MinnesotaCompletedAcute Myeloid Leukemia | Higher Risk Myelodysplastic SyndromeUnited States
-
Zhi-Hong Liu, M.D.TerminatedAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisChina
-
Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Chordia Therapeutics, Inc.TheradexRecruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesUnited States
-
Compass TherapeuticsActive, not recruitingMetastatic Colorectal Cancer | Rectal Cancer | Colon CancerUnited States
-
Compass TherapeuticsRecruitingHodgkin Lymphoma | Non Small Cell Lung Cancer | Triple Negative Breast Cancer | Head and Neck Squamous Cell Carcinoma | Malignant MelanomaUnited States
-
ReNeuron LimitedCompletedPeripheral Arterial DiseaseUnited Kingdom
-
Celtaxsys, Inc.Clinical Network Services (CNS) Pty Ltd; Celtaxsys Aus Pty LimitedCompletedAcne VulgarisAustralia, New Zealand
-
Celtaxsys, Inc.CompletedCystic FibrosisUnited States, United Kingdom, Canada, Belgium, France, Germany, Italy
-
Sheba Medical CenterUnknownCerebrotendinous Xanthomatosis (CTX)Israel