EUCTR2004-004917-41-CZ进行中（未招募）不适用
A prospective, randomized, active controlled, parallel group, multi-center trial to assess the efficacy and safety of mycophenolate mofetil (MMF) in inducing response and maintaining remission in subjects with lupus nephritis. - Aspreva Lupus Management Study (ALMS)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 358
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Induction Phase:
- •1. Provision of written informed consent by subject or guardian, (with written assent for underage subjects)
- •2. Subject of either sex, 12 to 75 years of age (inclusive)
- •3. Diagnosis of SLE according to the American College of Rheumatology criteria (1997)
- •4. Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis of lupus nephritis (ISN/RPS 2003 classification of lupus nephritis) classes III, IV-S or IV-G, (A) or (A/C), or class V, alone or in combination with class III or IV. For biopsies reported according to ISDKC/WHO 1982 criteria, see Protocol Appendix 4
- •5. Laboratory evidence of active nephritis at screening, defined as:
- •Class IV-S or IV-G
- •proteinuria =1000 mg/24 h or
- •serum creatinine above 1.3 mg/dL (115 µmol/L) or
- •active urinary sediment: any of >5 WBC/hpf, >5 RBC/hpf, 2+ or more on dipstick, or red cell casts in the absence of infection or other causes
- •Class III or V
- •proteinuria = 2000 mg/24 h or
- •serum creatinine above 1.3 mg/dL (115 µmol/L)
- •Maintenance Phase:
- •1. Response after 24 weeks of induction therapy (Visit 9) or complete (renal) remission.
- •Response is defined as:
- •Decrease in proteinuria, definded as decrease in the urine protein/creatinine ratio to <3 in subjects with baseline nephritic range proteinuria (>/=3 urine protein/creatinine ratio) or decrease in the urine protein/creatinine ratio by >/= 50% subjects with sub-nephrotic proteinuria (<3 urine protein/creatinine ratio). This ratio is based on the 24 hour urine collection.
- •and stabilization of serum creatinine (i.e. a week 24 serum creatinine level +/- 25% of baseline), or improvement.
- •Complete (renal) remission is defined as:
- •return to normal serum creatinine, proteinuria • and an inactive urinary sediment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Induction Phase:
- •1.Inability or unwillingness to provide written informed consent (and assent by underage subjects)
- •2. Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator
- •3. In the opinion of the investigator, does not require long-term immunosuppressive treatment (in addition to corticosteroids)
- •4. Known hypersensitivity or contraindication to MMF, mycophenolic acid (MPA), cyclophosphamide, azathioprine (including known inherited TPMT deficiency), corticosteroids or any components of these drug products (e.g., allergy to Tween-80)
- •5. Pregnancy, nursing (breastfeeding) or use of a non-reliable method of contraception
- •6. Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks
- •7. Previous kidney transplant or planned transplant
- •8. Presence or history of:
- •pancreatitis or GI hemorrhage within 6 months prior to first randomization
- •active unhealed peptic ulcer within 3 months prior to first randomization. If an ulcer has healed and the subject is on adequate therapy, the subject may be randomized
- •congenital or acquired immunodeficiency
- •clinically significant drug or alcohol abuse
- •malignancy within 5 years of first randomization, with the exception of basal cell carcinoma treated by complete excision
- •lymphoproliferative disease or previous total lymphoid irradiation
- •severe viral infection (CMV, HBV, HCV) within 3 months of first randomization; or known HIV infection
- •9. Other known clinically significant active medical conditions, such as:
- •severe cardiovascular disease including CHF
- •liver dysfunction [aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin greater than 2.5 times the upper limit of normal] measured on at least 2 separate occasions
- •COPD, or asthma requiring oral steroids
- •bone marrow insufficiency unrelated to active SLE (according to investigator judgment) with white blood cell count (WBC) <2500/mm3; absolute neutrophil count (ANC) <1.3 x 103/µL; thrombocytopenia (platelet count) <50,000/mm3
- •active bleeding disorders
- •current infection requiring IV antibiotics
- •10. Any overlapping autoimmune condition for which the condition or treatment of the condition may affect the study assessments or outcomes (e.g., scleroderma with significant pulmonary hypertension; any condition for which additional immunosuppression is indicated). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (e.g., Sjogren’s syndrome) are not excluded.
- •11. Other major physical or psychiatric illness or major traumatic injury within 6 months prior to first randomization
- •12. Other medical condition which, in the investigator’s judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
- •13.Participation in another clinical trial and/or receipt of investigational drugs within 4 weeks prior to screening visit
- •14. Use of medications prohibited prior to first randomization
- •Maintenance Phase:
- •1. Does not meet maintenance phase inclusion criteria.
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