Therapy of proliferative lupus glomerulonephritis: a prospective trial in The Netherlands

Proliferative glomerulonephritis is a severe clinical manifestation of systemic lupus erythematosus, and it remains a major determinant of morbidity and mortality in this disease, despite the progress that has been made by treating patients with a combination of corticosteroids and cytotoxic drugs. Earlier controlled clinical trials have demonstrated the superior efficacy of a combination of pulse cyclophosphamide with steroids over treatment with steroids alone. However, cyclophosphamide carries a substantial risk of short-term and long-term toxicity in this predominantly young population, and previous trials have not convincingly shown any benefit over the milder treatment with a combination of azathioprine and steroids. We propose to conduct a Dutch multicentre trial to test whether similar renal survival can be achieved with an azathioprine-based regimen, compared to the widely used cyclophosphamide treatment, with a possibly lower risk of adverse effects.