A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis

Phase 3

Completed

• Conditions: Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases; Circulatory System; ANCA associated vasculitis

• Registration Number: ISRCTN15366107
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30612116 (added 09/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-01-01
• Study Start: 2010-05-28
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. New diagnosis of ANCA-associated systemic vasculitis (AASV) (Wegener's granulomatosis [WG] or microscopic polyangiitis [MPA]) (within the previous six months)
2. Active disease (defined by at least one major or three minor BVAS 2003 items)
3. ANCA positivity (c-ANCA and PR3-ANCA or p-ANCA and MPO-ANCA) or histology confirming active vasculitis from any organ
4. Written informed consent
5. Aged 5 years or older, either sex

Exclusion Criteria

1. Previous treatment with:
1.1. MMF: more than two weeks ever
1.2. Cyclophosphamide: more than two weeks daily oral or more than 1 pulse of intravenous (IV) CYC (15 mg/kg)
1.3. Rituximab or high dose intravenous immunoglobulin within the last twelve months
2. Active infection (including hepatitis B, C, human immunodeficiency virus [HIV] and tuberculosis)
3. Known hypersensitivity to MMF, azathioprine (AZA) or CYC
4. Cancer or an individual history of cancer (other than resected basal cell skin carcinoma)
5. Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
6. Any condition judged by the investigator that would cause the study to be detrimental to the patient
7. Any other multi-system autoimmune disease including Churg Strauss angiitis, systemic lupus erythematosus (SLE), anti-glomerular basement membrane (anti-GBM) disease and cryoglobulinaemia
8. Active serious digestive system disease (e.g., inflammatory bowel disease)
9. Patients with imminently life threatening vasculitis (diffuse alveolar haemorrhage, intestinal perforation or major haemorrhage, cerebral vasculitis and cardiac vasculitis)
10. Patients with rapidly progressive glomerulonephritis and declining renal function. Defined as estimated glomerular filtration rate (GFR) fall greater than 20% in previous two weeks.
11. GFR less than 15 ml/min at entry or on dialysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified