Randomized controlled trial of pulse synchronization cyclophosphamide apheresis for proliferative lupus nephritis

OBJECTIVE: To assess the efficacy of pulse/synchronization cyclophosphamide /apheresis in patients with proliferative lupus nephritis. METHODS: Eightee n patients with Class III or IV renal biopsies and chronicity indices <6 we re prospectively randomized to receive 6 courses of parenteral cyclophospha mide over 8 months along with prednisone. Nine of these patients also recei ved 3 daily plasmaphereses prior to each of the 6 courses of cyclophosphami de. Assessments compiled at 6 and 24 months included serum creatinine, albu min, anti DNA, 24-hour urine protein, and C3 complement along with SLAM sco res. RESULTS: Two out of nine patients in each group evolved end stage rena l disease and 319 patients in each group went into a renal remission at 24 months. Serum albumin, C3 complement, and SLAM scores improved in both grou ps, and anti-DNA improved in the pulse/synchronization patients (P < 0.025) . No intergroup comparisons were significant. CONCLUSION: The addition of p ulse/synchronization apheresis to cyclophosphamide therapy does not improve the course of patients with proliferative lupus nephritis. J. Clin. Aphere sis 13:163-166, 1998. (C) 1998 Wiley-Liss, Inc.