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
Background 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. Methods We conducted a multicenter,...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
The Korean Society of Nephrology
2022-07-01
|
| Series: | Kidney Research and Clinical Practice |
| Subjects: | |
| Online Access: | http://www.krcp-ksn.org/upload/pdf/j-krcp-21-146.pdf |
| _version_ | 1818162541703987200 |
|---|---|
| author | Sang Youb Han Chan-Young Jung Sang Ho Lee Dong Won Lee Sik Lee Chan-Duck Kim Bum Soon Choi Beom Seok Kim |
| author_facet | Sang Youb Han Chan-Young Jung Sang Ho Lee Dong Won Lee Sik Lee Chan-Duck Kim Bum Soon Choi Beom Seok Kim |
| author_sort | Sang Youb Han |
| collection | DOAJ |
| description | Background 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. Methods 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) of >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. Results Among the 48 randomized patients, the percentage that achieved complete or partial remission was greater in thecombination therapy group than in the 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 and 0.07 ± 0.17 mg/mgCr in the treatment and control group, respectively (p = 0.04). Overall adverse events did not differ between the groups. Conclusion In advanced IgAN patients with a high risk for disease progression, combined MMF and corticosteroid therapy appears to be beneficial in reducing proteinuria and preserving renal function. |
| first_indexed | 2024-12-11T16:35:19Z |
| format | Article |
| id | doaj.art-a06b63a020ed40c08650de91934dd56c |
| institution | Directory Open Access Journal |
| issn | 2211-9132 2211-9140 |
| language | English |
| last_indexed | 2024-12-11T16:35:19Z |
| publishDate | 2022-07-01 |
| publisher | The Korean Society of Nephrology |
| record_format | Article |
| series | Kidney Research and Clinical Practice |
| spelling | doaj.art-a06b63a020ed40c08650de91934dd56c2022-12-22T00:58:29ZengThe Korean Society of NephrologyKidney Research and Clinical Practice2211-91322211-91402022-07-0141445246110.23876/j.krcp.21.1466123A 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 nephropathySang Youb Han0Chan-Young Jung1Sang Ho Lee2Dong Won Lee3Sik Lee4Chan-Duck Kim5Bum Soon Choi6Beom Seok Kim7 Department of Internal Medicine, Inje University College of Medicine, Goyang, Republic of Korea Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Republic of Korea Department of Internal Medicine, Pusan National University School of Medicine, Yangsan, Republic of Korea Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Republic of Korea Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Republic of Korea Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of KoreaBackground 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. Methods 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) of >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. Results Among the 48 randomized patients, the percentage that achieved complete or partial remission was greater in thecombination therapy group than in the 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 and 0.07 ± 0.17 mg/mgCr in the treatment and control group, respectively (p = 0.04). Overall adverse events did not differ between the groups. Conclusion In advanced IgAN patients with a high risk for disease progression, combined MMF and corticosteroid therapy appears to be beneficial in reducing proteinuria and preserving renal function.http://www.krcp-ksn.org/upload/pdf/j-krcp-21-146.pdfcorticosteroidsiga nephropathyimmunosuppressantsmycophenolate mofetilproteinuria |
| spellingShingle | Sang Youb Han Chan-Young Jung Sang Ho Lee Dong Won Lee Sik Lee Chan-Duck Kim Bum Soon Choi Beom Seok Kim 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 Kidney Research and Clinical Practice corticosteroids iga nephropathy immunosuppressants mycophenolate mofetil proteinuria |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | corticosteroids iga nephropathy immunosuppressants mycophenolate mofetil proteinuria |
| url | http://www.krcp-ksn.org/upload/pdf/j-krcp-21-146.pdf |
| work_keys_str_mv | AT sangyoubhan amulticenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT chanyoungjung amulticenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT sangholee amulticenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT dongwonlee amulticenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT siklee amulticenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT chanduckkim amulticenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT bumsoonchoi amulticenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT beomseokkim amulticenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT sangyoubhan multicenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT chanyoungjung multicenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT sangholee multicenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT dongwonlee multicenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT siklee multicenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT chanduckkim multicenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT bumsoonchoi multicenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy AT beomseokkim multicenterrandomizedopenlabelcomparativephaseivstudytoevaluatetheefficacyandsafetyofcombinedtreatmentwithmycophenolatemofetilandcorticosteroidsinadvancedimmunoglobulinanephropathy |