Effect of pulsed intravenous methylprednisolone with alternative low-dose prednisone on high-risk IgA nephropathy: a 18-month prospective clinical trial

• Published in: Scientific reports Vol. 12; no. 1; p. 255
• Main Authors: Li, Yan, Fu, Rongguo, Gao, Jie, Wang, Li, Duan, Zhaoyang, Tian, Lifang, Ge, Heng, Ma, Xiaotao, Zhang, Yuzhan, Li, Ke, Xu, Peihao, Tian, Xuefei, Chen, Zhao
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 07.01.2022; Nature Publishing Group; Nature Portfolio
• Subjects: 692/4022; 692/4022/1585/2759/1522; Administration, Intravenous; Administration, Oral; Adult; Biopsy; ChiCTR; ChiCTR1800014442; Clinical trials; Cushing syndrome; Disease Progression; Drug Tapering; Drug Therapy, Combination; Female; Glomerulonephritis, IGA - diagnosis; Glomerulonephritis, IGA - drug therapy; Glomerulonephritis, IGA - immunology; Glucocorticoids; Glucocorticoids - administration & dosage; Glucocorticoids - adverse effects; Humanities and Social Sciences; Humans; IgA nephropathy; Immunoglobulin A; Intravenous administration; Kidney Failure, Chronic - immunology; Kidney Failure, Chronic - prevention & control; Male; Methylprednisolone; Methylprednisolone - administration & dosage; Methylprednisolone - adverse effects; multidisciplinary; Patients; Prednisone; Prednisone - administration & dosage; Prednisone - adverse effects; Prospective Studies; Proteinuria; Proteinuria - diagnosis; Proteinuria - drug therapy; Proteinuria - immunology; Pulse Therapy, Drug; Remission; Remission Induction; Risk Assessment; Risk Factors; Science; Science (multidisciplinary); Time Factors; Treatment Outcome
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-021-03691-0

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/ ).