From: Interventions for renal vasculitis in adults. A systematic review
Study ID | Inclusion criteria | Exclusion criteria |
---|---|---|
Hu 2008 | Newly diagnosed active ANCA associated vasculitis. Over 18 years of age with renal involvement with serum creatinine < 500 uM. ANCA positive or ANCA negative with confirmatory renal Biopsy | Cytotoxic drug treatment in 6 months prior. HBV, HCV, HIV or active CMV viral infection, acquired immune deficiency, severe renal failure with creatinine > 500 uM or on renal replacement therapy, life-threatening organ manifestations (lung haemorrhage or CNS involvement), active TB, liver dysfunction, pregnancy or inadequate contraception if female, under age 18 or over 65. |
Jones 2008 (RITUXVAS) | A new diagnosis of Wegener's Granulomatosis (WG), Microscopic Polyangiitis (MP) or Renal-Limited Vasculitis (RLV) Renal involvement attributable to active WG, MP or RLV with at least one of the following: Biopsy demonstrating necrotizing glomerulonephritis Red cell casts on urine microscopy or ≥++ haematuria Anti-Neutrophil Cytoplasmic Antibodies (ANCA) positivity; ANCA positivity requires either: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) by Enzyme-Linked Immunosorbent Assay (ELISA) or a typical anti-neutrophil cytoplasmic antibody (cANCA) pattern by indirect immunofluorescence (IIF), or both Myeloperoxidase-anti-neutrophil cytoplasmic antibody (MPO-ANCA) by ELISA. A positive peri-nuclear anti-neutrophil cytoplasmic antibody (pANCA) by IIF requires confirmation by MPO-ANCA ELISA. | 1. Previous cyclophosphamide, (greater than two weeks of an oral or intravenous [IV] pulse cyclophosphamide regimen) 2. Co-existence of another multi-system autoimmune disease, e.g. SLE, Churg Strauss syndrome, Henoch Schonlein purpura, rheumatoid vasculitis, essential mixed cryoglobulinaemia, anti-glomerular basement membrane antibody positivity 3. Hepatitis B antigen positive or hepatitis C antibody positive 4. Known HIV positive (HIV testing will not be a requirement for this trial) 5. Previous malignancy (usually exclude unless agreed with trial co-ordinator) 6. Pregnancy, breast feeding or inadequate contraception if female 7. Allergy to a study medication 8. Live vaccine within last four weeks |
Stone 2009 (RAVE) | Weight of at least 88 lbs (40 kg). Diagnosis of Wegener's granulomatosis (WG) or microscopic polyangiitis (MPA) according to the definitions of the Chapel Hill Consensus Conference. Newly diagnosed patient of WG or MPA OR must be experiencing a disease flare characterized by: (a) active disease with a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 3 or greater that would normally require treatment with CPA; OR (b) disease severe enough to require treatment with CPA; OR (c) must be positive for either PR3-ANCA or MPO-ANCA at the screening. Willing to use acceptable forms of contraception for the duration of the study and for up to 1 year after stopping study medications. Willing to report pregnancies (female participants or male participants' partners) occurring at any time during the study and for up to 1 year after stopping study medications. Parent or guardian willing to provide informed consent, if applicable. | Churg-Strauss Syndrome Limited disease that would not normally be treated with CPA. Mechanical ventilation because of alveolar haemorrhage History of severe allergic reactions to human or chimeric monoclonal antibodies. Active systemic infection. Deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia complicated by pleural cavity or lung abscess, within 6 months prior to study entry. History of or current hepatitis B or C infection. HIV infected. Acute or chronic liver disease. History of or active cancer diagnosed within the last 5 years. History of anti-glomerular basement membrane (anti-GBM) disease. Other uncontrolled disease, including drug and alcohol abuse. Pregnancy or breastfeeding. |
Jayne 2000 | Prior diagnosis of Wegener's granulomatosis or microscopic polyangiitis ANCA positivity at diagnosis. Active vasculitis with a requirement for further therapy. At least 2 months treatment with prednisolone and cyclophosphamide or azathioprine Age 18 or over | IVIg in previous 3 months history of anaphylaxis to matched blood products selective IgA deficiency RPGN (20% rise in creatinine in 2 weeks) or pulmonary haemorrhage. |
Furuta 1998 | Biopsy proven rapidly progressive GN. | None Stated |
Stegmayr 1999 | RPGN ≥ 50% crescents; included WG, Goodpasture's syndrome, MPA | HIV, hepatitis A, B or C virus, severe congestive heart failure, malignancy, septicaemia. |