Plasma exchange and glucocorticoid dosing in the treatment of antineutrophil cytoplasm antibody associated vasculitis

Not Applicable

Completed

• Conditions: Anti-neutrophil cytoplasm antibody associated vasculitis (AAV) with nephritis or lung haemorrhage; Mental and Behavioural Disorders; Other necrotising vasculopathies

• Registration Number: ISRCTN07757494
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

2013 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/23497590 protocol 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32053298 results (added 14/02/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36155131/ (added 27/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-22
• Study Completion: 2018-07-31
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

1. New or previous clinical diagnosis of Wegener's granulomatosis, or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions
2. Positive test for proteinase 3-ANCA or myeloperoxidase-ANCA
3. Severe vasculitis defined by at least one of the following:
3.1. Renal involvement, characterised by:
3.1.1. Renal biopsy demonstrating focal necrotising glomerulonephritis or active urine sediment demonstrating glomerular haematuria/red cell casts and proteinuria, and
3.1.2. Estimated glomerular filtration rate (eGFR) less than 50 ml/min/1.73 m2), or
3.2. Pulmonary haemorrhage due to active vasculitis (defined by a compatible chest x-ray or computed tomography [CT] scan (diffuse pulmonary infiltrates), and
3.3. The absence of an alternative explanation for all pulmonary infiltrates (i.e. volume overload or pulmonary infection), and
3.4. At least one of the following:
3.4.1. Evidence of alveolar haemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage
3.4.2. Observed haemoptysis
3.4.3. Unexplained anaemia (less than 10 g/dl) or documented drop in haemoglobin (greater than 1 g/dl)
3.4.4. An increased diffusing capacity of carbon dioxide
4. Provision of informed consent by patient or a surrogate decision maker
5. Aged greater than or equal to 15 years, either sex

Exclusion Criteria

1. A diagnosis of vasculitis other than Wegener's 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 greater than 21 days immediately prior to randomisation or prior renal transplant
4. Aged less than 15 years (aged less than 18 years at centres that do not treat paediatric patients)
5. Pregnancy
6. Treatment with greater than 1 intravenous (IV) dose of cyclophosphamide and/or greater than 14 days of oral cyclophosphamide and/or greater than 14 days of prednisone/prednisolone (greater than 30 mg/day) and/or greater than 1 dose of rituximab within the 28 days immediately prior to randomisation
7. 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

Added 30/10/2019:
8. Plasma exchange in 3 months prior to randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death or end-stage renal disease. Timepoint for all analyses is the common closeout date (2 years after the last patient is enrolled).