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Abstract
Full-dose prednisone (FP) regimen in the treatment of high-risk immunoglobulin A nephropathy (IgAN) patients, is still controversial. The pulsed intravenous methylprednisolone combined with alternative low-dose prednisone (MCALP) might have a more favorable safety profile, which has not been fully investigated. Eighty-seven biopsy-proven IgAN adult patients and proteinuria between 1 and 3.5 g/24 h after ACEI/ARB for at least 90 days were randomly assigned to 6-month therapy: (1) MCALP group: 0.5 g of methylprednisolone intravenously for three consecutive days at the beginning of the course and 3rd month respectively, oral prednisone at a dose of 15 mg every other day for 6 months. (2) FP group: 0.8–1.0 mg/kg/days of prednisone (maximum 70 mg/day) for 2 months, then tapered by 5 mg every 10 days for the next 4 months. All patients were followed up for another 12 months. The primary outcome was complete remission (CR) of proteinuria at 12 months. The percentage of CR at 12th and 18th month were similar in the MCALP and FP groups (51% vs 58%, P = 0.490, at 12th month; 60% vs 56%, P = 0.714, at 18th month). The cumulative dosages of glucocorticoid were less in the MCALP group than FP group (4.31 ± 0.26 g vs 7.34 ± 1.21 g, P < 0.001). The analysis of the correlation between kidney biopsy Oxford MEST-C scores with clinical outcomes indicated the percentages of total remission was similar between two groups with or without M1, E1, S1, T1/T2, and C1/C2. More patients in the FP group presented infections (8% in MCALP vs 21% in FP), weight gain (4% in MCALP vs 19% in FP) and Cushing syndrome (3% in MCALP vs 18% in FP). These data indicated that MCALP maybe one of the choices for IgAN patients with a high risk for progression into ESKD.Trial registration: The study approved by the Chinese Clinical Trial Registry (registration date 13/01/2018, approval number ChiCTR1800014442, https://www.chictr.org.cn/).
Highlights
Immunoglobulin A nephropathy (IgAN), known as Berger’s d isease[1], is one of the most prevalent types of primary glomerulonephritis in the Asia–Pacific region that is an important cause of end-stage kidney disease (ESKD)
Another retrospective study designed by Hotta et al.[18] using steroid pulse therapy (500 mg/day for 3 days for three courses followed by oral prednisolone at an initial dose of 0.6 mg/kg on alternate days, with a gradual decrease in dosage over 1 year), which included IgAN patients with proteinuria greater than 0.5 g/24 h, confirmed that steroid pulse therapy had a higher response rate
How to assess the correlation between the kidney pathological Oxford MEST-C scores and clinical outcomes for high-risk IgAN patients that have not been studied in these aforementioned clinical trials including the TESTING, STOP-IgAN et al Based on these findings and our long-term clinical experience on the treatment of IgAN patients, we compared the efficacy and safety of pulsed intravenous methylprednisolone combined with alternative low-dose prednisone (MCALP) and full-dose prednisone (FP) regimen in high-risk IgAN patients with persistent proteinuria more than 1 g/24 h, the correlation between the kidney pathological Oxford MEST-C scores and clinical outcomes were investigated in this study
Summary
Immunoglobulin A nephropathy (IgAN), known as Berger’s d isease[1], is one of the most prevalent types of primary glomerulonephritis in the Asia–Pacific region that is an important cause of end-stage kidney disease (ESKD). The results of prospective STOP-IgA20,21 showed that glucocorticoids treatment has no additional favorable effects on the outcomes but more side events for the high-risk IgAN patients compared to the intensive supportive care alone during the 3-year study phase, and subsequently the extended follow-up phase (median follow-up was 7.4 years). In spite of these findings, how to treat high-risk IgAN patients with appropriate glucocorticoid dosages and regimens effectively and safely needs more in-depth investigation. The study was approved by the Chinese Clinical Trial Registry (registration date 13/01/2018, approval number ChiCTR1800014442, https://www.chictr.org.cn/)
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