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Astellas Study ID
F506-CL-0912

A study to compare the efficacy and safety of Tacrolimus capsules and Cyclophosphamide injection in treatment of lupus nephritis

Astellas Study ID
NCT02457221
Clinicaltrials.gov ID
NCT02457221
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

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.

Additional Study Details

Phase
3
Product
  • Tacrolimus capsules
  • Cyclophosphamide injections
  • Prednisone
    • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    314
    Show Additional Study Details

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    Would you like more information about clinical trial sites that are recruiting participants for A study to compare the efficacy and safety of Tacrolimus capsules and Cyclophosphamide injection in treatment of lupus nephritis? Contact us by filling out your information to the right and we’ll respond to you.

    • A caregiver
    • A healthcare provider
    • A parent
    • A patient
    • A patient advocate
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    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
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    • Bulgaria
    • Canada
    • Chile
    • China
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    • Former Serbia and Montenegro
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    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
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      Site CN00020
      Shijiazhuang, Hebei, China
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      Site CN00041
      Xiamen, Fujian, China
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      Site CN00034
      Beijing, Beijing, China
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      Changchun, Jilin, China
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      Nanjing, Jiangsu, China
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      Shijiazhuang, Hebei, China
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      Shenzhen, Guangdong, China
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      Shanghai, Shanghai, China
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      Hefei, Anhui, China
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      Chengdu, Sichuan, China
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      Changsha, Hunan, China
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      Site CN00030
      Beijing, Beijing, China
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      Shanghai, Shanghai, China
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      Lishui, Zhejiang, China
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      Site CN00045
      Liuzhou, Guangxi, China
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      Nanning, Guangxi, China
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      Guangzhou, Guangdong, China
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      Wulumuqi, Xinjiang, China
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      Hangzhou, Zhejiang, China
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      Shenyang, Liaoning, China
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      Nanjing, Jiangsu, China
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      Shenyang, Liaoning, China
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      Nanning, Guangxi, China
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      Tianjin, Tianjin, China
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      Wuhan, Hubei, China
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      Site CN00028
      Zhengzhou, Henan, China
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      Site CN00013
      Nanjing, Jiangsu, China
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      Wuxi, Jiangsu, China
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      Site CN00052
      Taiyuan, Shanxi, China
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      Site CN00032
      Qingdao, Shandong, China
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      Site CN00021
      Tianjin, Tianjin, China
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      Site CN00024
      Wuhan, Hubei, China
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      Site CN00042
      Changchun, Jilin, China
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      Site CN00003
      Chengdu, Sichuan, China
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      Site CN00015
      Shanghai, Shanghai, China
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      Site CN00050
      Changsha, Hunan, China
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      Site CN00005
      Dalian, Liaoning, China
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      Trial info
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      Age
      18 - 60 years
      Diamond icon
      Condition
    • Lupus
      • Gender icon
      Sex
      Female & Male
      Calendar icon
      Trial Dates
      Mar 2015 - Sep 2018
      Additional Study Details
      Inclusion Criteria

        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

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