We propose the continuation of a controlled, prospective study of the effects of plasmapheresis on the short-term and long-term courses of patients with severe forms of lupus glomerulonephritis. Plasmapheresis (plasma exchange) is a costly but unproven therapy in this disease. The continuation of this clinical trial of 125 patients followed for up to 6 years is proposed, the primary endpoint being mortality or renal failure. The Biostatistical Coordinating Center provides support for this collaborative trial in the study design (procedures, forms, randomization), execution (data processing support, editing, updating corrections, monitoring performance of clinics, patient safety data monitoring) and final statistical analysis and publications.
| Levey, A S; Lan, S P; Corwin, H L et al. (1992) Progression and remission of renal disease in the Lupus Nephritis Collaborative Study. Results of treatment with prednisone and short-term oral cyclophosphamide. Ann Intern Med 116:114-23 |
