J Korean Med Sci.  2018 Feb;33(9):e74. 10.3346/jkms.2018.33.e74.

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

Affiliations
  • 1Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea. sh-park@knu.ac.kr
  • 2Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • 3Department of Internal Medicine, Inje University, Haeundae Paik Hospital, Busan, Korea.
  • 4Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • 5Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
  • 6Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
  • 7Department of Internal Medicine, Yeungnam University Hospital, Daegu, Korea.
  • 8Department of Internal Medicine, College of Medicine, Dong-A University, Busan, Korea.
  • 9Department of Internal Medicine, Fatima Hospital, Daegu, Korea.

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 (www.ClinicalTrials.gov 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 (www.ClinicalTrials.gov NCT01282073).

Keyword

Membranous Nephropathy; Cyclosporine; Mycophenolate Mofetil; Corticosteroids

MeSH Terms

Adrenal Cortex Hormones*
Cyclosporine*
Glomerular Filtration Rate
Glomerulonephritis, Membranous*
Humans
Proteinuria
Quality of Life
Adrenal Cortex Hormones
Cyclosporine
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