The effect of mycophenolate mofetil versus cyclosporine as combination therapy with low dose corticosteroids in high-risk patients with idiopathic membranous nephropathy: A multicenter randomized trial

Ji Young Choi, Dong Ki Kim, Yang Wook Kim, Tae Hyun Yoo, Jung Pyo Lee, Hyun Chul Chung, Kyu Hyang Cho, Won Suk An, Duk Hyun Lee, Hee Yeon Jung, Jang Hee Cho, Chan Duck Kim, Yong Lim Kim, Sun Hee Park

Research output: Contribution to journalArticle

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Abstract

Background: Appropriate immunosuppressive therapy for patients with idiopathic membranous nephropathy (MN) remains controversial. The effect of mycophenolate mofetil (MMF) versus cyclosporine (CsA) combined with low-dose corticosteroids was evaluated in patients with idiopathic MN in a multi-center randomized trial (NCT01282073). Methods: A total of 39 biopsy-proven idiopathic MN patients with severe proteinuria were randomly assigned to receive MMF combined with low-dose corticosteroids (MMF group) versus CsA combined with low-dose corticosteroids (CsA group), respectively, and followed up for 48 weeks. Complete or partial remission rate of proteinuria and estimated glomerular filtration rate (eGFR) at 48 weeks were compared. Results: The level of proteinuria at baseline and at 48 weeks was 8.9 ± 5.9 and 2.1 ± 3.1 g/day, respectively, in the MMF group compared to 8.4 ± 3.5 and 3.2 ± 5.7 g/day, respectively, in the CsA group. In total, 76.1% of the MMF group and 66.7% of the CsA group achieved remission at 48 weeks (95% confidence interval, -0.18 to 0.38). There was no difference in eGFR between the two groups. Anti-phospholipase A2 receptor Ab levels at baseline decreased at 48 weeks in the complete or partial remission group (P = 0.001), but were unchanged in the no-response group. There were no significant differences between the two groups in changes in the Gastrointestinal Symptom Rating Scale and Gastrointestinal Quality of Life Index scores from baseline to 48 weeks. Conclusion: In combination with low-dose corticosteroids, the effect of MMF may not be inferior to that of CsA in patients with idiopathic MN, with similar adverse effects including gastrointestinal symptoms. Trial registry at ClinicalTrials.gov (NCT01282073).

Original languageEnglish
Article numbere74
JournalJournal of Korean medical science
Volume33
Issue number9
DOIs
Publication statusPublished - 2018 Jan 1

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Mycophenolic Acid
Membranous Glomerulonephritis
Cyclosporine
Multicenter Studies
Adrenal Cortex Hormones
Proteinuria
Glomerular Filtration Rate
Phospholipase A2 Receptors
Therapeutics
Immunosuppressive Agents
Registries
Quality of Life
Confidence Intervals
Biopsy

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Choi, Ji Young ; Kim, Dong Ki ; Kim, Yang Wook ; Yoo, Tae Hyun ; Lee, Jung Pyo ; Chung, Hyun Chul ; Cho, Kyu Hyang ; An, Won Suk ; Lee, Duk Hyun ; Jung, Hee Yeon ; Cho, Jang Hee ; Kim, Chan Duck ; Kim, Yong Lim ; Park, Sun Hee. / The effect of mycophenolate mofetil versus cyclosporine as combination therapy with low dose corticosteroids in high-risk patients with idiopathic membranous nephropathy : A multicenter randomized trial. In: Journal of Korean medical science. 2018 ; Vol. 33, No. 9.
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abstract = "Background: Appropriate immunosuppressive therapy for patients with idiopathic membranous nephropathy (MN) remains controversial. The effect of mycophenolate mofetil (MMF) versus cyclosporine (CsA) combined with low-dose corticosteroids was evaluated in patients with idiopathic MN in a multi-center randomized trial (NCT01282073). Methods: A total of 39 biopsy-proven idiopathic MN patients with severe proteinuria were randomly assigned to receive MMF combined with low-dose corticosteroids (MMF group) versus CsA combined with low-dose corticosteroids (CsA group), respectively, and followed up for 48 weeks. Complete or partial remission rate of proteinuria and estimated glomerular filtration rate (eGFR) at 48 weeks were compared. Results: The level of proteinuria at baseline and at 48 weeks was 8.9 ± 5.9 and 2.1 ± 3.1 g/day, respectively, in the MMF group compared to 8.4 ± 3.5 and 3.2 ± 5.7 g/day, respectively, in the CsA group. In total, 76.1{\%} of the MMF group and 66.7{\%} of the CsA group achieved remission at 48 weeks (95{\%} confidence interval, -0.18 to 0.38). There was no difference in eGFR between the two groups. Anti-phospholipase A2 receptor Ab levels at baseline decreased at 48 weeks in the complete or partial remission group (P = 0.001), but were unchanged in the no-response group. There were no significant differences between the two groups in changes in the Gastrointestinal Symptom Rating Scale and Gastrointestinal Quality of Life Index scores from baseline to 48 weeks. Conclusion: In combination with low-dose corticosteroids, the effect of MMF may not be inferior to that of CsA in patients with idiopathic MN, with similar adverse effects including gastrointestinal symptoms. Trial registry at ClinicalTrials.gov (NCT01282073).",
author = "Choi, {Ji Young} and Kim, {Dong Ki} and Kim, {Yang Wook} and Yoo, {Tae Hyun} and Lee, {Jung Pyo} and Chung, {Hyun Chul} and Cho, {Kyu Hyang} and An, {Won Suk} and Lee, {Duk Hyun} and Jung, {Hee Yeon} and Cho, {Jang Hee} and Kim, {Chan Duck} and Kim, {Yong Lim} and Park, {Sun Hee}",
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The effect of mycophenolate mofetil versus cyclosporine as combination therapy with low dose corticosteroids in high-risk patients with idiopathic membranous nephropathy : A multicenter randomized trial. / Choi, Ji Young; Kim, Dong Ki; Kim, Yang Wook; Yoo, Tae Hyun; Lee, Jung Pyo; Chung, Hyun Chul; Cho, Kyu Hyang; An, Won Suk; Lee, Duk Hyun; Jung, Hee Yeon; Cho, Jang Hee; Kim, Chan Duck; Kim, Yong Lim; Park, Sun Hee.

In: Journal of Korean medical science, Vol. 33, No. 9, e74, 01.01.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The effect of mycophenolate mofetil versus cyclosporine as combination therapy with low dose corticosteroids in high-risk patients with idiopathic membranous nephropathy

T2 - A multicenter randomized trial

AU - Choi, Ji Young

AU - Kim, Dong Ki

AU - Kim, Yang Wook

AU - Yoo, Tae Hyun

AU - Lee, Jung Pyo

AU - Chung, Hyun Chul

AU - Cho, Kyu Hyang

AU - An, Won Suk

AU - Lee, Duk Hyun

AU - Jung, Hee Yeon

AU - Cho, Jang Hee

AU - Kim, Chan Duck

AU - Kim, Yong Lim

AU - Park, Sun Hee

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: Appropriate immunosuppressive therapy for patients with idiopathic membranous nephropathy (MN) remains controversial. The effect of mycophenolate mofetil (MMF) versus cyclosporine (CsA) combined with low-dose corticosteroids was evaluated in patients with idiopathic MN in a multi-center randomized trial (NCT01282073). Methods: A total of 39 biopsy-proven idiopathic MN patients with severe proteinuria were randomly assigned to receive MMF combined with low-dose corticosteroids (MMF group) versus CsA combined with low-dose corticosteroids (CsA group), respectively, and followed up for 48 weeks. Complete or partial remission rate of proteinuria and estimated glomerular filtration rate (eGFR) at 48 weeks were compared. Results: The level of proteinuria at baseline and at 48 weeks was 8.9 ± 5.9 and 2.1 ± 3.1 g/day, respectively, in the MMF group compared to 8.4 ± 3.5 and 3.2 ± 5.7 g/day, respectively, in the CsA group. In total, 76.1% of the MMF group and 66.7% of the CsA group achieved remission at 48 weeks (95% confidence interval, -0.18 to 0.38). There was no difference in eGFR between the two groups. Anti-phospholipase A2 receptor Ab levels at baseline decreased at 48 weeks in the complete or partial remission group (P = 0.001), but were unchanged in the no-response group. There were no significant differences between the two groups in changes in the Gastrointestinal Symptom Rating Scale and Gastrointestinal Quality of Life Index scores from baseline to 48 weeks. Conclusion: In combination with low-dose corticosteroids, the effect of MMF may not be inferior to that of CsA in patients with idiopathic MN, with similar adverse effects including gastrointestinal symptoms. Trial registry at ClinicalTrials.gov (NCT01282073).

AB - Background: Appropriate immunosuppressive therapy for patients with idiopathic membranous nephropathy (MN) remains controversial. The effect of mycophenolate mofetil (MMF) versus cyclosporine (CsA) combined with low-dose corticosteroids was evaluated in patients with idiopathic MN in a multi-center randomized trial (NCT01282073). Methods: A total of 39 biopsy-proven idiopathic MN patients with severe proteinuria were randomly assigned to receive MMF combined with low-dose corticosteroids (MMF group) versus CsA combined with low-dose corticosteroids (CsA group), respectively, and followed up for 48 weeks. Complete or partial remission rate of proteinuria and estimated glomerular filtration rate (eGFR) at 48 weeks were compared. Results: The level of proteinuria at baseline and at 48 weeks was 8.9 ± 5.9 and 2.1 ± 3.1 g/day, respectively, in the MMF group compared to 8.4 ± 3.5 and 3.2 ± 5.7 g/day, respectively, in the CsA group. In total, 76.1% of the MMF group and 66.7% of the CsA group achieved remission at 48 weeks (95% confidence interval, -0.18 to 0.38). There was no difference in eGFR between the two groups. Anti-phospholipase A2 receptor Ab levels at baseline decreased at 48 weeks in the complete or partial remission group (P = 0.001), but were unchanged in the no-response group. There were no significant differences between the two groups in changes in the Gastrointestinal Symptom Rating Scale and Gastrointestinal Quality of Life Index scores from baseline to 48 weeks. Conclusion: In combination with low-dose corticosteroids, the effect of MMF may not be inferior to that of CsA in patients with idiopathic MN, with similar adverse effects including gastrointestinal symptoms. Trial registry at ClinicalTrials.gov (NCT01282073).

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U2 - 10.3346/jkms.2018.33.e74

DO - 10.3346/jkms.2018.33.e74

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