EUCTR2016-004045-81-PL进行中（未招募）1 期
A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Achieving Renal Response in Subjects with Active Lupus Nephritis - AURORA (AURinia Orelvo Renal Assessments) 1: Aurinia Renal Response in Active Lupus with Voclosporin
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
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
入选标准
- •Written informed consent before any study specific procedures are performed.
- •Male or female subjects with a minimum age of 18 (or legal age of consent if >18 years) to 75 years of age, inclusive, at the time of screening (Visit 1).
- •Previous diagnosis of SLE according to the American College of Rheumatology criteria
- •Subjects with evidence of active nephritis, defined as follows:
- •- Kidney biopsy result within 2 years prior to screening indicating Class III, IV S, IV-G (alone or in combination with Class V), or Class V LN (see Appendix 3) with a doubling or greater increase of urine protein creatinine ratio (UPCR) within the last 6 months to a minimum of =1.5 mg/mg for Class III/IV or to a minimum of =2 mg/mg for Class V at screening. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility.
- •- Kidney biopsy result within 6 months prior to screening indicating Class III, IV S or IV-G (alone or in combination with Class V) LN with a UPCR of =1.5 mg/mg at screening.
- •- Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of =2 mg/mg at screening.
- •A biopsy can be performed during screening, if not available. The above criteria must be fulfilled at baseline.
- •In the opinion of the Investigator, subject requires high-dose corticosteroids and immunosuppressive therapy.
- •Subject is willing to take oral MMF for the duration of the study, either by continuing current MMF therapy or by initiating it on or before the Baseline Visit.
- •Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. Two effective forms of contraception must be used simultaneously unless abstinence is the chosen method. Subjects must use effective contraception during the study
- •Are the trial subjects under 18? no
- •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 310
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.
- •Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of =45 mL/minute/1.73 m2 at screening confirmed before randomization.
- •Currently taking or known need for any of the medications listed in protocol Section 7.8, Prohibited Therapy and Concomitant Treatment at screening or during the study. This includes prohibited medications prior to screening as specified in protocol Section 7.8.1, Prohibited Medications.
- •Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- •A previous kidney transplant or planned transplant within study treatment period.
- •Any known hypersensitivity or contraindication to MMF, mycophenolic acid, cyclosporine, corticosteroids or any components of these drug products.
- •Current or medical history of:
- •- Congenital or acquired immunodeficiency.
- •- In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
- •- Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed.
- •- Lymphoproliferative disease or previous total lymphoid irradiation.
- •- Severe viral infection (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus) within 3 months of screening; or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy.
- •- Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid (see protocol Section 9.2.1, Screening Visit Procedures).
- •Other known clinically significant active medical conditions, such as:
- •- Severe cardiovascular disease including congestive heart failure, history of cardiac dysrhythmia or congenital long QT syndrome. QT interval duration corrected for heart rate using method of Fridericia exceeding 480 msec in the presence of a normal QRS interval (<110 msec) at time of screening will result in exclusion.
- •- Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin =2.5 times the upper limit of normal) at screening and, if abnormal at screening, then confirmed that the levels have returned to <2.5 times upper limit of normal before randomization.
- •- Chronic obstructive pulmonary disease or asthma requiring oral steroids.
- •- Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count <2,500/mm3; absolute neutrophil count <1.3 × 10(3)/µL; thrombocytopenia (platelet count <50,000/mm3).
- •- Active bleeding disorders.
- •- Current infection requiring IV antibiotics.
- •Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (e.g
研究者
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