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)

Aspreva Pharmaceuticals Corporation as part of the Roche-Aspreva Collaboration Agreement0 个研究点目标入组 358 人开始时间: 2006年1月17日最近更新: 2012年5月1日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 358

研究概览入排标准研究者记录与标识符相似试验

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

•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)
•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

•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

研究者

发起方

Aspreva Pharmaceuticals Corporation as part of the Roche-Aspreva Collaboration Agreement

相似试验

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)upus NephritisMedDRA version: 4.1Level: LowClassification code 10025140

EUCTR2004-004917-41-CZAspreva International Ltd.358

进行中（未招募）

不适用

EUCTR2004-004917-41-BEAspreva International Ltd.358

进行中（未招募）

1 期

EUCTR2004-004917-41-GBAspreva International Ltd.370

进行中（未招募）

不适用

EUCTR2004-004917-41-DEAspreva International Ltd.358

尚未招募

3 期

A clinical trial to evaluate the efficacy and safety of topical eutectic mixture of Lidocaine + Prilocaine in patients requiring dermal anaesthesia.

CTRI/2010/091/000504Themis Medicare Limited240