Condition category
Circulatory System
Date applied
31/01/2006
Date assigned
21/02/2006
Last edited
15/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.vasculitis.org

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 measures

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

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

Sponsor information

Organisation

Addenbrookes Hospital NHS Trust (UK)

Sponsor details

Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17582159

Publication citations

  1. 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.

Additional files

Editorial Notes