Leflunomide plus low-dose prednisone in patients with progressive IgA nephropathy : a multicenter, prospective, randomized, open-labeled, and controlled trial
BACKGROUND: Immunoglobulin A nephropathy (IgAN) is the most common cause of glomerulonephritis worldwide, and the optimal approach to its treatment remains a significant challenge.
METHODS: We did a prospective, randomized, open-labeled, multicenter, controlled trial, comprised of 3-month run-in, 12-month treatment, and 12-month follow-up phases. After 3-month run-in phase, patients with biopsy-confirmed IgAN at risk of progression were randomly allocated to LEF plus low-dose prednisone (LEF + prednisone group) or conventionally accepted-dose prednisone [prednisone(alone) group] Our primary outcome was 24-h urine protein excretion (UPE) and secondary outcomes were serum albumin (sALB), serum creatinine (Scr), and eGFR. Safety was evaluated in all patients who received the trial medications.
RESULTS: One hundred and eight patients [59 in LEF + prednisone group, 49 in prednisone (alone) group]were enrolled and finished their treatment and follow-up periods. There is no significant difference in the baseline level between the two groups. Compared with baseline, both groups showed a significant decrease in 24-h UPE (p < 0.01) and increase in sALB (p < 0.01), with stable Scr and eGFR throughout the 12-month treatment period. What's more, these effects were sustained through the 12-month follow-up period. However, there was no difference in 24-h UPE, sALB, Scr, and eGFR between the two groups (p > 0.05). At 12 months, a difference in overall response rate, relapsing rate, and incidence of adverse events between the two groups was not significant.
CONCLUSIONS: The efficacy and safety of LEF plus low-dose prednisone and conventionally accepted-dose prednisone in the treatment of progressive IgAN are comparable.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:43 |
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| Enthalten in: |
Renal failure - 43(2021), 1 vom: 16. Dez., Seite 1214-1221 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ni, Zhaohui [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 20.12.2021 Date Revised 25.04.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.1080/0886022X.2021.1963775 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM329406272 |
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| 245 | 1 | 0 | |a Leflunomide plus low-dose prednisone in patients with progressive IgA nephropathy |b a multicenter, prospective, randomized, open-labeled, and controlled trial |
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| 500 | |a Date Revised 25.04.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Immunoglobulin A nephropathy (IgAN) is the most common cause of glomerulonephritis worldwide, and the optimal approach to its treatment remains a significant challenge | ||
| 520 | |a METHODS: We did a prospective, randomized, open-labeled, multicenter, controlled trial, comprised of 3-month run-in, 12-month treatment, and 12-month follow-up phases. After 3-month run-in phase, patients with biopsy-confirmed IgAN at risk of progression were randomly allocated to LEF plus low-dose prednisone (LEF + prednisone group) or conventionally accepted-dose prednisone [prednisone(alone) group] Our primary outcome was 24-h urine protein excretion (UPE) and secondary outcomes were serum albumin (sALB), serum creatinine (Scr), and eGFR. Safety was evaluated in all patients who received the trial medications | ||
| 520 | |a RESULTS: One hundred and eight patients [59 in LEF + prednisone group, 49 in prednisone (alone) group]were enrolled and finished their treatment and follow-up periods. There is no significant difference in the baseline level between the two groups. Compared with baseline, both groups showed a significant decrease in 24-h UPE (p < 0.01) and increase in sALB (p < 0.01), with stable Scr and eGFR throughout the 12-month treatment period. What's more, these effects were sustained through the 12-month follow-up period. However, there was no difference in 24-h UPE, sALB, Scr, and eGFR between the two groups (p > 0.05). At 12 months, a difference in overall response rate, relapsing rate, and incidence of adverse events between the two groups was not significant | ||
| 520 | |a CONCLUSIONS: The efficacy and safety of LEF plus low-dose prednisone and conventionally accepted-dose prednisone in the treatment of progressive IgAN are comparable | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a IgA nephropathy | |
| 650 | 4 | |a disease progression | |
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| 650 | 4 | |a leflunomide | |
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| 700 | 1 | |a Mei, Changlin |e verfasserin |4 aut | |
| 700 | 1 | |a Ding, Xiaoqiang |e verfasserin |4 aut | |
| 700 | 1 | |a Yuan, Weijie |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Jiang, Gengru |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Min |e verfasserin |4 aut | |
| 700 | 1 | |a He, Liqun |e verfasserin |4 aut | |
| 700 | 1 | |a Deng, Yueyi |e verfasserin |4 aut | |
| 700 | 1 | |a Pang, Huihua |e verfasserin |4 aut | |
| 700 | 1 | |a Qian, Jiaqi |e verfasserin |4 aut | |
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