Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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 Vasculitis Study group.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Treatments: Cyclophosphamide

Criteria

Inclusion Criteria:

1. A new diagnosis of WG, MP or renal-limited vasculitis (RLV) (appendix 5). Patients not previously treated with cytotoxic drugs will be permitted.

2. 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.

3. 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).

4. Age 18-80 years.

Exclusion Criteria:

1. 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.

2. Co-existence of another multisystem autoimmune disease, e.g. SLE.

3. Hepatitis Be antigen positive or Hepatitis C antibody positive.

4. Known HIV positivity (HIV testing will not be a requirement for this trial).

5. Serum creatinine > 500umol/l (consider MEPEX trial).

6. Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence).

7. Previous malignancy (usually exclude unless agreed with trial co-ordinator).

8. Pregnancy or inadequate contraception if female.

9. Anti-GBM antibody positivity.