European Community SYStemic VASculitis TRIALs group
| ISRCTN | ISRCTN03001669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03001669 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/01/2006
- Registration date
- 21/02/2006
- Last edited
- 15/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Jayne
Scientific
Scientific
Box 118
Renal Unit
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 217259 |
|---|---|
| dj106@cam.ac.uk |
Study information
| Study design | Interventional, randomised, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ECSYSVASTRIAL |
| Study objectives | Plasma exchange is superior to high dose intravenous methylprednisolone in the treatment of severe renal vasculitis. |
| Ethics approval(s) | Received from the Cambridge Local Research Ethics Committee in March 1995. |
| Health condition(s) or problem(s) studied | ANCA associated vasculitis |
| Intervention | Plasma exchange versus high dose intravenous methyl prednisolone |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methyl prednisolone |
| Primary outcome measure | Renal recovery at three months |
| Secondary outcome measures | End stage renal disease at one year, severe adverse events |
| Overall study start date | 01/03/1995 |
| Completion date | 31/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/1995 |
| Date of final enrolment | 31/01/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box 118
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Addenbrookes Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
England
United Kingdom
"ROR" |
https://ror.org/055vbxf86 |
|---|
Funders
Funder type
Government
European Union (Belgium) - Biomedical and Health Research Programme (BIOMED) (contract number BMH4-CT97-2328)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/07/2007 | Yes | No |
