Plasma exchange and glucocorticoid dosing in the treatment of ANCA-associated vasculitis: a multicentre randomized controlled tria - PEXIVAS

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA0 个研究点目标入组 704 人开始时间: 2009年12月10日最近更新: 2021年12月21日

试验速览

暂无简介。

•1. New or previous clinical diagnosis of Wegeners granulomatosis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions AND
•2. Positive test for proteinase 3-ANCA or myeloperoxidase-ANCA AND
•3. Severe vasculitis defined by at least one of the following:
•a. Renal involvement with both:
•i. Renal biopsy demonstrating focal necrotizing glomerulonephritis or active urine sediment characterized by glomerular haematuria or red cell casts and proteinuria
•ii. eGFR <50 ml/min/1.73 m2
•b. Pulmonary hemorrhage due to active vasculitis defined by:
•i. A compatible chest x-ray or CT scan (diffuse pulmonary infiltrates)
•ii. The absence of an alternative explanation for all pulmonary infiltrates (e.g. volume overload or pulmonary infection)
•iii. At least one of the following:
•1. Evidence of alveolar hemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage
•2. Observed hemoptysis
•3. Unexplained anemia (<10 g/dL) or documented drop in hemoglobin (>1 g/dL)
•4. Increased diffusing capacity of carbon dioxide
•4. Provision of informed consent by patient or a surrogate decision maker
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. A diagnosis of vasculitis other than Wegeners granulomatosis or microscopic polyangiitis
•2. Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition
•3. Receipt of dialysis for >21 days immediately prior to randomization or prior renal transplant
•4. Age <15 years (age <18 years at centres that do not treat pediatric patients)
•5. Pregnancy
•6. Inability or unwillingness to comply with birth control/abstinence
•7. Treatment with >1 IV dose of cyclophosphamide and/or >14 days of oral cyclophosphamide and/or >14 days of prednisone/prednisolone (>30 mg/day) and/or >1 dose of rituximab within the 28 days immediately prior to randomization
•8. A comorbidity that, in the opinion of the investigator, precludes the use of cyclophosphamide, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma exchange

发起方

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA