Contact information
Type
Scientific
Primary contact
Dr David Jayne
ORCID ID
Contact details
Box 118
Renal Unit
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217259
dj106@cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ECSYSVASTRIAL
Study hypothesis
Plasma exchange is superior to high dose intravenous methylprednisolone in the treatment of severe renal vasculitis.
Ethics approval
Received from the Cambridge Local Research Ethics Committee in March 1995.
Study design
Interventional, randomised, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
ANCA associated vasculitis
Intervention
Plasma exchange versus high dose intravenous methyl prednisolone
Intervention type
Drug
Phase
Not Specified
Drug names
Methyl prednisolone
Primary outcome measure
Renal recovery at three months
Secondary outcome measures
End stage renal disease at one year, severe adverse events
Overall trial start date
01/03/1995
Overall trial end date
31/01/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. New diagnosis of Wegener granulomatosis (WG), micropolyarteritis (MP) or its renal-limited variant, in accordance with the Chapel Hill Consensus criteria, with active vasculitis, as indicated by the presence of active necrotising glomerulonephritis on renal biopsy
2. Anti-neutrophilic cytoplasmic antibodies (ANCA) positivity: either a typical cytoplasmic-ANCA pattern by immunofluorescence test (IIF), and/or positivity in the proteinase-3 enzyme-linked immunosorbent assay (Pr3 ELISA), or positivity in the myeloperoxidase (MPO) ELISA, with or without perinuclear-ANCA (ANCA result will be confirmed by a nominated reference laboratory)
3. Biopsy-proven necrotising and/or crescentic glomerulonephritis, in the absence of another defined glomerulopathy, with severe renal impairment as defined by either:
3.1. Oliguria (less than 400 ml/24 hr) or
3.2. Intention to commence dialysis within 48 hours of admission
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Aged less than 18 or over 80
2. Inadequate contraception in women of child-bearing age
3. Pregnancy
4. Usually exclude patients with previous malignancy (unless agreed with trial coordinators)
5. Hepatitis B antigenaemia or detectable anti-hepatitis C virus antibody
6. Known anti-human immunodeficiency virus (anti-HIV) (HIV testing is not a requirement for this trial)
7. Diagnosis of Churg-Strauss syndrome, Henoch-Schonlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia, systemic lupus erythematosus, or the presence of circulating anti-glomerular basement membrane (anti-GBM) antibodies and linear gamma G immunoglobulin (IgG) staining of the GBM on renal biopsy, with intent to treat as anti-GBM mediated nephritis
8. Life-threatening non-renal manifestations of vasculitis, including alveolar haemorrhage requiring mechanical ventilation within 24 hours of admission
9. On dialysis for more than two weeks prior to referral
10. Significant baseline renal impairment: creatinine greater than 200 mmol/l one year or more before presentation
11. A second clearly defined cause of renal failure (e.g. urinary tract obstruction; not acute tubular necrosis [ATN])
12. Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis
13. Intravenous methylprednisolone (IVMeP), plasma exchange (PE) or pulsed intravenous cyclophosphamide within the preceding year
14. More than two weeks treatment with oral cyclophosphamide (Cyc) or azathioprine (Aza)
15. More than three months treatment with oral corticosteroids (OCS)
16. Allergy to study medications (excluding prophylactic agents)
17. Previous IVMeP therapy, which exceeds a single dose of 500 mg prior to referral to the participating centre
Recruitment start date
01/03/1995
Recruitment end date
31/01/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Box 118
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Government
Funder name
European Union (Belgium) - Biomedical and Health Research Programme (BIOMED) (contract number BMH4-CT97-2328)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/17582159
Publication citations
-
Results
Jayne DR, Gaskin G, Rasmussen N, Abramowicz D, Ferrario F, Guillevin L, Mirapeix E, Savage CO, Sinico RA, Stegeman CA, Westman KW, van der Woude FJ, de Lind van Wijngaarden RA, Pusey CD, , Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis., J. Am. Soc. Nephrol., 2007, 18, 7, 2180-2188, doi: 10.1681/ASN.2007010090.