A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lupus Nephritis
Intervention: Tacrolimus capsules (Drug); Cyclophosphamide injections (Drug); Prednisone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Astellas Pharma China, Inc. Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Astellas Pharma China, Inc.
Overall contact: Astellas Pharma China, Inc., Phone: +(86) 10-85216333, Email: Astellas.registration@astellas.com
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Remission rate (complete remission + partial remission)
Secondary outcome: 24-hour urine proteinChange of 24-hour urine protein from baseline Serum albumin Change of Serum albumin from baseline Serum creatinine Change of Serum creatinine from baseline eGFR comparing with baseline Percentage of patients converted to other immunosuppressive therapy Percentage of patients with serum creatinine rising to two times of the baseline Percentage of patients with dsDNA and ANA converting from positive to negative SLE-DAI Immune parameters assessed by ESR, C3, C4 and dsDNA Change of SLE-DAI from baseline Change of immune parameters from baseline Renal biopsy AI (Active Index) CI (Chronic Index) Change of Renal biopsy AI (Active Index) from baseline Change of CI (Chronic Index) from baseline
Detailed description:
This is a randomized, open, 1: 1 parallel controlled, multi-center, non-inferiority clinical
study.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Astellas Pharma China, Inc., Phone: +(86) 10-85216333, Email: Astellas.registration@astellas.com
Site: 11, Beijing, China; Recruiting
Site: 12, Beijing, China; Recruiting
Site: 17, Fujian, China; Recruiting
Site: 3, Guangdong, China; Recruiting
Site: 14, Guangxi, China; Recruiting
Site: 13, Guangzhou, China; Recruiting
Site: 10, Henan, China; Recruiting
Site: 15, Hubei, China; Recruiting
Site: 16, Hubei, China; Recruiting
Site: 18, Hunan, China; Recruiting
Site: 4, Jiangsu, China; Recruiting
Site: 8, Jiangsu, China; Recruiting
Site: 9, Jilin, China; Recruiting
Site: 7, Liaoning, China; Recruiting
Site: 2, Shandong, China; Recruiting
Site: 5, Shandong, China; Recruiting
Site: 6, Shanghai, China; Recruiting
Site: 1, Sichuan, China; Recruiting
Additional Information
Starting date: March 2015
Last updated: May 27, 2015
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