Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: A randomised controlled trial.
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Author(s)
Type
Journal Article
Abstract
Background: Tacrolimus (TAC) is effective in treating membranous nephropathy (MN);
however relapses are frequent after treatment cessation. We conducted a randomised
controlled trial to examine whether the addition of mycophenolate mofetil (MMF) to TAC
would reduce relapse rate.
Methods: 40 patients with biopsy proven idiopathic MN and nephrotic syndrome were
randomly assigned to receive either TAC monotherapy (n=20) or TAC combined with MMF
(n=20) for 12 months. When patients had been in remission for 1 year on treatment the MMF
was stopped and the TAC gradually withdrawn in both groups over 6 months. Patients also
received supportive treatment with angiotensin blockade, statins, diuretics and
anticoagulation as needed. Primary endpoint was relapse rate following treatment
withdrawal. Secondary outcomes were remission rate, time to remission and change in renal
function.
Results: 16/20 (80%) of patients in the TAC group achieved remission compared to 19/20
(95%) in the TAC/MMF group (p=0.34). The median time to remission in the TAC group
was 54 weeks compared to 40 weeks in the TAC/MMF group (p=0.46). There was no
difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group
relapsed compared to 8/19 (42%) in the TAC/MMF group (p=0.7). The addition of MMF to
TAC did not adversely affect the safety of the treatment.
Conclusions: Addition of MMF to TAC does not alter the relapse rate of nephrotic syndrome
in patients with MN.
however relapses are frequent after treatment cessation. We conducted a randomised
controlled trial to examine whether the addition of mycophenolate mofetil (MMF) to TAC
would reduce relapse rate.
Methods: 40 patients with biopsy proven idiopathic MN and nephrotic syndrome were
randomly assigned to receive either TAC monotherapy (n=20) or TAC combined with MMF
(n=20) for 12 months. When patients had been in remission for 1 year on treatment the MMF
was stopped and the TAC gradually withdrawn in both groups over 6 months. Patients also
received supportive treatment with angiotensin blockade, statins, diuretics and
anticoagulation as needed. Primary endpoint was relapse rate following treatment
withdrawal. Secondary outcomes were remission rate, time to remission and change in renal
function.
Results: 16/20 (80%) of patients in the TAC group achieved remission compared to 19/20
(95%) in the TAC/MMF group (p=0.34). The median time to remission in the TAC group
was 54 weeks compared to 40 weeks in the TAC/MMF group (p=0.46). There was no
difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group
relapsed compared to 8/19 (42%) in the TAC/MMF group (p=0.7). The addition of MMF to
TAC did not adversely affect the safety of the treatment.
Conclusions: Addition of MMF to TAC does not alter the relapse rate of nephrotic syndrome
in patients with MN.
Date Issued
2019-09-06
Date Acceptance
2019-08-06
Citation
BMC Nephrology, 2019, 20, pp.1-9
ISSN
1471-2369
Publisher
BioMed Central
Start Page
1
End Page
9
Journal / Book Title
BMC Nephrology
Volume
20
Copyright Statement
© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Identifier
https://bmcnephrol.biomedcentral.com/articles/10.1186/s12882-019-1539-z
Subjects
Science & Technology
Life Sciences & Biomedicine
Urology & Nephrology
Membranous nephropathy
Nephrotic syndrome
Relapse
Mycophenolate mofetil
Tacrolimus
Randomised controlled trial
LONG-TERM
NEPHROPATHY
CYCLOSPORINE
RITUXIMAB
IMMUNOSUPPRESSION
COMBINATION
MONOTHERAPY
THERAPY
TARGET
Membranous nephropathy
Mycophenolate mofetil
Nephrotic syndrome
Randomised controlled trial
Relapse
Tacrolimus
1103 Clinical Sciences
Urology & Nephrology
Publication Status
Published
Article Number
352
Date Publish Online
2019-08-25