Status:
COMPLETED
Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
ANCA Associated Systemic Vasculitis
Wegener's Granulomatosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
A comparison of intermittent pulsed cyclophosphamide to daily oral cyclophosphamide for the treatment of ANCA-associated systemic vasculitides with kidney involvement. Performed by the European Vascu...
Detailed Description
The primary, ANCA-associated systemic vasculitides (AASV), including Wegener's granulomatosis and microscopic polyangiitis, are progressive, multisystem, autoimmune diseases which respond to immunosup...
Eligibility Criteria
Inclusion
- A new diagnosis of WG, MP or renal-limited vasculitis (RLV) (appendix 5). Patients not previously treated with cytotoxic drugs will be permitted.
- Renal involvement attributable to active WG, MP or RLV with at least one of the following:
- elevated serum creatinine between 150 and 500 umol/l.
- biopsy demonstrating necrotizing glomerulonephritis.
- red cell casts.
- haematuria with \>30 red blood cells/high powered field and proteinuria \> 1g/24hr.
- ANCA positivity or confirmatory histology or both (appendix 5). ANCA positivity requires a typical CANCA pattern by indirect immunofluorescence (IIF), (preferably confirmed by anti-PR3 ELISA), or the presence of PR3-ANCA or MPO-ANCA determined by ELISA, PANCA requires confirmation by anti-MPO ELISA \[6\]. (Central review of ANCA serology and histology will be performed).
- Age 18-80 years.
Exclusion
- More than two weeks treatment with cyclophosphamide (CYC) or other cytotoxic drug within previous year or with oral corticosteroids (OCS) for more than 4 weeks. If the patient has received \>1.0g of methyl-prednisolone prior to the study start, discuss with trial co-ordinator.
- Co-existence of another multisystem autoimmune disease, e.g. SLE.
- Hepatitis Be antigen positive or Hepatitis C antibody positive.
- Known HIV positivity (HIV testing will not be a requirement for this trial).
- Serum creatinine \> 500umol/l (consider MEPEX trial).
- Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence).
- Previous malignancy (usually exclude unless agreed with trial co-ordinator).
- Pregnancy or inadequate contraception if female.
- Anti-GBM antibody positivity.
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00430105
Start Date
February 1 1998
End Date
April 1 2004
Last Update
February 1 2007
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