PMCID: PMC3562866 DOI: 10.2215/CJN.08330812
BACKGROUND AND OBJECTIVES: In the FSGS Clinical Trial, 22 cyclosporine-treated and 20 mycophenolate/dexamethasone-treated patients experienced a complete or partial remission after 26 weeks, completed 52 weeks of treatment, and were studied through 78 weeks. Herein, changes in the urine protein/creatinine ratio (UP/C) and estimated GFR (eGFR) throughout the entire study period are defined.
DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: The FSGS Clinical Trial, which was conducted from November 2004 to January 2010, enrolled patients aged 2-40 years, with eGFR ≥40 ml/min per 1.73 m(2) and UP/C >1 mg/mg after ≥4 weeks of corticosteroid therapy. Both groups received lisinopril or losartan throughout the study. UP/C and eGFR were measured at 0, 26, 52, and 78 weeks.
RESULTS: The median UP/C in the cyclosporine- and mycophenolate/dexamethasone-responsive patients fell by 89.8% and 82.7% at 52 weeks; the fall was largely sustained at 78 weeks (74.7% and 80.3%, respectively). The mean eGFR fell by 19.4% in the cyclosporine group and rose by 7.0% in the mycophenolate mofetil/dexamethasone group at 52 weeks, but subsequently rose by 16.4% and fell by 2.6%, respectively, in the two groups from 52 to 78 weeks.
CONCLUSIONS: In this subset of responding FSGS patients, the improvement in UP/C after cyclosporine or mycophenolate/dexamethasone treatment was largely sustained for 6 months after therapy. Reduction in eGFR in the cyclosporine group was improved 6 months after cyclosporine was stopped although the levels were lower than baseline in seven patients who entered the study with decreased eGFR.
Clin J Am Soc Nephrol
Adolescent; Adult; Child; Child, Preschool; Cyclosporine; Dexamethasone; Drug Therapy, Combination; Female; Glomerulosclerosis, Focal Segmental; Humans; Immunosuppression; Immunosuppressive Agents; Kidney Function Tests; Male; Mycophenolic Acid; Prospective Studies; Proteinuria; Young Adult
Hogg, R. J., Friedman, A., Greene, T., Radeva, M., Budisavljevic, M. N., Gassman, J., Gipson, D. S., Jefferson, J. A., John, E. G., Kaskel, F. J., Moudgil, A., Moxey-Mims, M., Ortiz, L. A., Schelling, J. R., Schnaper, W., Srivastava, T., Trachtman, H., Vehaskari, V. M., Wong, C., Woronieki, R. P., Van Why, S. K., Zolotnitskaya, A. Renal function and proteinuria after successful immunosuppressive therapies in patients with FSGS. Clin J Am Soc Nephrol 8, 211-218 (2013).