A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis

October 30, 2024 updated by: Astellas Pharma China, Inc.

A Phase III, Randomized, Open, Parallel-controlled, Multi-center Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis

The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.

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.

Detailed Description

This is a randomized, open, 1:1 parallel controlled, multi-center, non-inferiority clinical study.

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.
314

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
    • Anhui
      • Hefei, Anhui, China
        • Site CN00043
    • Beijing
      • Beijing, Beijing, China
        • Site CN00030
      • Beijing, Beijing, China
        • Site CN00034
    • Fujian
      • Xiamen, Fujian, China
        • Site CN00041
    • Guangdong
      • Guangzhou, Guangdong, China
        • Site CN00056
      • Shenzhen, Guangdong, China
        • Site CN00017
    • Guangxi
      • Liuzhou, Guangxi, China
        • Site CN00045
      • Nanning, Guangxi, China
        • Site CN00037
      • Nanning, Guangxi, China
        • Site CN00038
    • Hebei
      • Shijiazhuang, Hebei, China
        • Site CN00020
      • Shijiazhuang, Hebei, China
        • Site CN00047
    • Henan
      • Zhengzhou, Henan, China
        • Site CN00028
    • Hubei
      • Wuhan, Hubei, China
        • Site CN00023
      • Wuhan, Hubei, China
        • Site CN00024
    • Hunan
      • Changsha, Hunan, China
        • Site CN00027
      • Changsha, Hunan, China
        • Site CN00050
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Site CN00012
      • Nanjing, Jiangsu, China
        • Site CN00013
      • Nanjing, Jiangsu, China
        • Site CN00025
      • Wuxi, Jiangsu, China
        • Site CN00049
    • Jilin
      • Changchun, Jilin, China
        • Site CN00026
      • Changchun, Jilin, China
        • Site CN00042
    • Liaoning
      • Dalian, Liaoning, China
        • Site CN00005
      • Shenyang, Liaoning, China
        • Site CN00018
      • Shenyang, Liaoning, China
        • Site CN00019
    • Shandong
      • Qingdao, Shandong, China
        • Site CN00032
    • Shanghai
      • Shanghai, Shanghai, China
        • Site CN00001
      • Shanghai, Shanghai, China
        • Site CN00014
      • Shanghai, Shanghai, China
        • Site CN00015
    • Shanxi
      • Taiyuan, Shanxi, China
        • Site CN00052
    • Sichuan
      • Chengdu, Sichuan, China
        • Site CN00002
      • Chengdu, Sichuan, China
        • Site CN00003
    • Tianjin
      • Tianjin, Tianjin, China
        • Site CN00021
    • Xinjiang
      • Wulumuqi, Xinjiang, China
        • Site CN00044
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Site CN00010

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 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18.5≤Body Mass Index (BMI) <27;
  • Diagnosed as systemic lupus erythematosus (based on American Rheumatism Association Diagnostic Criteria 1997)
  • Diagnosed as III, IV, V, III + V, IV + V lupus nephritis (according to the LN classification in International Society of Nephrology and Renal Pathology Society (ISN/RPS) 2003) within 24 weeks before enrollment with renal biopsy;
  • 24-hour urine protein ≥ 1.5g, Scr<260umol/L (or 3mg/dL)

Exclusion Criteria:

  • Class II or VI lupus nephritis or renal biopsy chronic index (CI) > 3 or with TMA;
  • Received immunosuppressants (mycophenolate mofetil (MMF), cyclosporine, methotrexate, mechlorethamine, chlorambucil, tripterygium preparations, leflunomide etc.) treatment with a duration of more than one week within 30 days prior to enrollment;
  • Received tacrolimus (except for topical use) or cyclophosphamide treatment within 30 days prior to enrollment;
  • Received a course of methylprednisolone (MP) pulse therapy or gamma globulin treatment or plasma exchange within 30 days prior to enrollment;
  • Patients with history of allergies to tacrolimus, cyclophosphamide or methylprednisolone;
  • Pregnancy, lactation or patient unwilling to take contraceptive measures;
  • Patients with estimated maintenance dialysis for more than eight weeks; or dialysis for more than two weeks prior to entering observation;
  • Patients received kidney transplantation or plan to have kidney transplantation recently;
  • Serum creatinine (Scr) ≥260umol/L (or 3mg/dL) or creatinine clearance rate (Ccr) < 30ml/(min.1.73m2); according to Cockcroft-Gault formula: Ccr (ml/sec) = [(140- age)× Weight (kg)] × K / [72×Scr (umol/L) ×0.6786], Female K = 0.85, Male K = 1.0;
  • Patients suffering from liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times the upper limit of normal lab value) or bilirubin more than 3 times the upper limit of normal lab value;
  • Patients diagnosed with diabetes;
  • History of gastrointestinal bleeding or pancreatitis within 3 months;
  • Uncontrollable hyperkalemia after dietary therapy or reduction of potassium treatment (exceed the upper limit of normal lab value);
  • Patients suffering from lupus pneumonia or lung injury;
  • Patients with anemia (hemoglobin <7g/dl) or bone marrow suppression (WBC <3.0×109/L, and/or neutrophils <1.5×109/L, and/or platelets <50×109/L) not secondary to systemic lupus erythematosus;
  • With congenital heart disease, arrhythmia, heart failure or other severe cardiovascular diseases;
  • With refractory hypertension (defined as blood pressure still exceeds 180/110 mmHg despite taking three different types of antihypertensive drugs [one of them is diuretic] simultaneously);
  • Patients with recurrent tumors within 5 years;
  • Severe infection that requires intravenous antibiotics within 2 weeks prior to enrollment;
  • Patients with infection of hepatitis B virus or hepatitis C virus; patients with active tuberculosis; patients with severe immunodeficiency diseases (including active cytomegalovirus infection (positive CMV IgM antibody), or human immunodeficiency virus (HIV) infection, etc.);
  • Patients with lupus encephalopathy or other life-threatening complication of systemic lupus erythematosus;
  • Patients participated in other clinical trials within three months before enrollment

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: Tacrolimus group
Tacrolimus capsules + steroid
Drug: Prednisone
oral
Drug: Tacrolimus capsules
oral
Other Names:
  • Prograf
Active Comparator: Cyclophosphamide group
Cyclophosphamide injections + steroid
Drug: Prednisone
oral
Drug: Cyclophosphamide injections
intravenous injection

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
Measure Description
Time Frame
Remission rate (complete remission + partial remission)
Time Frame: at 24 weeks
complete remission: urine protein < 0.5g/24hr, and serum albumin≥3.5g/dl, and stable renal function (Scr increase ≤ 15% baseline value) partial remission: urine protein 0.5-3.5g/24hr (≥ 0.5 g/24hr and < 3.5 g/24hr), and urine protein decreased by >50% comparing with the baseline, and serum albumin ≥ 3.0g/dl, and stable renal function (Scr increase ≤ 15% baseline value)
at 24 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
Measure Description
Time Frame
24-hour urine protein
Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Change of 24-hour urine protein from baseline
Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Serum albumin
Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Change of Serum albumin from baseline
Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Serum creatinine
Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Change of Serum creatinine from baseline
Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
eGFR comparing with baseline
Time Frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
eGFR: Estimated Glomerular Filtration Rate
at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Percentage of patients converted to other immunosuppressive therapy
Time Frame: during 24 weeks
during 24 weeks
Percentage of patients with serum creatinine rising to two times of the baseline
Time Frame: during 24 weeks
during 24 weeks
Percentage of patients with dsDNA and ANA converting from positive to negative
Time Frame: during 24 weeks
ANA: Antinuclear Antibody
during 24 weeks
SLE-DAI
Time Frame: at Week 4, 12 and 24
SLE-DAI: Systemic Lupus Erythematosus - Disease Activity Index
at Week 4, 12 and 24
Immune parameters assessed by ESR, C3, C4 and dsDNA
Time Frame: at Week 4, 12 and 24
ESR: Erythrocyte Sedimentation Rate, C3, C4: Complement C3, C4, dsDNA: Anti-Double-Stranded DNA Antibodies
at Week 4, 12 and 24
Change of SLE-DAI from baseline
Time Frame: at Week 4, 12 and 24
at Week 4, 12 and 24
Change of immune parameters from baseline
Time Frame: at Week 4, 12 and 24
at Week 4, 12 and 24
Renal biopsy AI (Active Index)
Time Frame: at Week 24
at Week 24
CI (Chronic Index)
Time Frame: at Week 24
at Week 24
Change of Renal biopsy AI (Active Index) from baseline
Time Frame: at Week 24
at Week 24
Change of CI (Chronic Index) from baseline
Time Frame: at Week 24
at Week 24

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.
Astellas Pharma China, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma China, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

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.
March 10, 2015

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.
September 10, 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.
September 10, 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).
May 22, 2015

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.
May 27, 2015

First Posted (Estimated)

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.
May 29, 2015

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.
November 1, 2024

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.
October 30, 2024

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.
October 1, 2024

More Information

Terms related to this study

Keywords

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.
  • F506-CL-0912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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