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. This application proposes support for the Clinical Coordinating Center of the Lupus Nephritis Collaborative Study Group. A separate applicaton proposes support of the Biostatistical Coordinating Center. The trial involved 15 collaborating clinics. A population of 125 patients will be followed for periods of up to 6 years. The primary end point is mortality or renal failure. The clinical management protocols are designed to attain the following purposes: (1) To determine whether plasmapheresis has a beneficial effect in this population - a group of patients with severe lupus glomerulonephritis defined in precise histologic terms are being randomly assigned to therapy with (a) prednisone plus cyclophosphamide, or (b) plasmapheresis plus prednisone/cyclophosphamide. The patients are assigned to this primary protocol at entry and later in the trial if they fulfill the definition of a severe recurrent manifectation of lupus glomerulonephritis. (2) The second purpose of the protocols is to provide a mechanism for standardized definition and managment of intercurrent complications of the disease process or its management. Lupus being a complicated disease, these protocols attempt to take into account intercurrent events in order to provide some uniformity to the overall management of the patients during the period of time that they are being studied. The goal of this study is to determine whether plasmapheresis contributes to improvement of the prognosis of a population of lupus patients with serious glomerular disease. In addition to the primary end points of mortality and renal failure, other variables being studied include rate of loss of renal function, rate of appearance of intercurrent renal and nonrenal exacerbations, the amount of prednisone administered during the period of study and the incidence of complications.
| 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 |
| Pohl, M A; Lan, S P; Berl, T (1991) Plasmapheresis does not increase the risk for infection in immunosuppressed patients with severe lupus nephritis. The Lupus Nephritis Collaborative Study Group. Ann Intern Med 114:924-9 |
