A multicenter, randomized, open-label, comparative, phase IV study to evaluate the efficacy and safety of combined treatment with mycophenolate mofetil and corticosteroids in advanced immunoglobulin A nephropathy

• Published in: Kidney research and clinical practice Vol. 41; no. 4; pp. 452 - 461
• Main Authors: Han, Sang Youb, Jung, Chan-Young, Lee, Sang Ho, Lee, Dong Won, Lee, Sik, Kim, Chan-Duck, Choi, Bum Soon, Kim, Beom Seok
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society of Nephrology 01-07-2022; 대한신장학회
• Subjects: corticosteroids; iga nephropathy; immunosuppressants; mycophenolate mofetil; Original; proteinuria; 내과학; Immunosuppressants; Corticosteroids; IgA nephropathy; Mycophenolate mofetil; Proteinuria
• ISSN: 2211-9132; 2211-9140
• DOI: 10.23876/j.krcp.21.146

It remains unclear whether immunosuppressive agents are effective in patients with immunoglobulin A nephropathy (IgAN). We investigated the efficacy of a mycophenolate mofetil (MMF) and corticosteroid combination therapy in patients with advanced IgAN.
We conducted a multicenter, randomized, placebo-controlled, parallel-group study of 48 weeks administration of MMF and corticosteroids in biopsy-proven advanced IgAN patients with estimated glomerular filtration rate (eGFR) of 20-50 mL/min/1.73 m2 and urine protein-to-creatinine ratio (UPCR) greater than 0.75 g/day. The primary outcome was complete (UPCR < 0.3 g/day) or partial (>50% reduction of UPCR compared to baseline) remission at 48 weeks.
Among the 48 randomized patients, the percentage that achieved complete or partial remission was greater in the group receiving MMF and corticosteroid than in the placebo control group (4.2% vs. 0% and 29.1% vs. 5.0%, respectively). Compared with the combination therapy group, eGFR in the control group decreased significantly from week 36 onward, resulting in a final adjusted mean change of -4.39 ± 1.22 mL/min/1.73 m2 (p = 0.002). The adjusted mean changes after 48 weeks were 0.62 ± 1.30 and -5.11 ± 1.30 mL/min/1.73 m2 (p = 0.005) in the treatment and control groups, respectively. The UPCR was significantly different between the two groups; the adjusted mean difference was -0.47 ± 0.17 mg/mgCr in the treatment group and 0.07 ± 0.17 mg/mgCr in the control group (p = 0.04). Overall adverse events did not differ between the groups.
In advanced IgAN patients with a high risk for disease progression, combination therapy of MMF and corticosteroid appears to be beneficial in reducing proteinuria and preserving renal function.