Cyclosporine withdrawal from a mycophenolate mofetil???containing immunosuppressive regimen in stable kidney transplant recipients: a randomized, controlled study1,2

Abramowicz, Daniel; Manas, Derek; Lao, M; Vanrenterghem, Yves; Castillo, Domingo del; Wijngaard, Peter; Fung, Samson

doi:10.1097/00007890-200212270-00015

Cited by 120 publications

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“…Thus, considering the incidence of AR previously reported in different randomized trials (11)(12)(13) and in our study, the new immunosuppressive drug MMF did not lead to a completely safe CsA discontinuation. Otherwise, the two pivotal trials of CsA elimination conducted with sirolimus showed different results.…”

Section: Discussionsupporting

confidence: 68%

“…In stable renal transplant recipients, CsA withdrawal under MMF was also found to be a safe procedure on the basis of the risk of AR and renal function (8,9), although histologic deterioration was observed in 50% of patients (10). Finally, the incidence of AR after CsA discontinuation under MMF was evaluated in three randomized trials (11)(12)(13). The risk for AR was found to be significantly increased in two of these studies (11,12), and a trend to a higher incidence was shown in the third one (13).…”

mentioning

confidence: 99%

“…Finally, the incidence of AR after CsA discontinuation under MMF was evaluated in three randomized trials (11)(12)(13). The risk for AR was found to be significantly increased in two of these studies (11,12), and a trend to a higher incidence was shown in the third one (13). However, renal function, hypertension, and lipid profile were improved, especially in patients who were withdrawn successfully from CsA.…”

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confidence: 99%

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Predictive Factors of Acute Rejection after Early Cyclosporine Withdrawal in Renal Transplant Recipients Who Receive Mycophenolate Mofetil

Hazzan¹,

Labalette²,

Copin³

et al. 2005

Journal of the American Society of Nephrology

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The aim of this randomized, open-labeled trial was to compare the incidence of acute rejection after an early (3 mo posttransplantation) withdrawal of cyclosporine (CsA) or mycophenolate mofetil (MMF) in renal transplantation. Among 218 eligible recipients, 108 nonsensitized, rejection-free patients who were under a triple drug regimen (CsA-MMF-prednisone) and had received a first kidney from a deceased donor were enrolled. At 3 mo after graft, they were gradually withdrawn from CsA (MMF group, n ‫؍‬ 54) or MMF (CsA group, n ‫؍‬ 54). A graft biopsy and a pharmacokinetic study of CsA and mycophenolic acid were systematically performed before the randomization. At 1 yr, graft and patient survival rates were 100% in each group. Renal function was improved in the MMF group compared with the CsA group (Cockcroft calculated clearance 64.7 ؎ 18.7 versus 56.5 ؎ 18.0 ml/min; P ‫؍‬ 0.023). However, the probability of acute rejection was higher in the MMF group (18.5 versus 5.6%; P ‫؍‬ 0.045). The 10 patients who developed acute rejection after CsA withdrawal had a significantly higher incidence of borderline changes on the randomization biopsy than the 44 rejection-free patients (five of 10 versus eight of 44; P ‫؍‬ 0.034), and they displayed a lower area under the curve of mycophenolic acid (43 ؎ 9 versus 58 ؎ 22 mg/h per L; P ‫؍‬ 0.045). Multivariate analysis confirmed that borderline changes and area under the curve of mycophenolic acid were significant risk factors of acute rejection after CsA discontinuation. It is concluded that a systematic graft biopsy and a pharmacokinetic study of mycophenolic acid are needed to reduce the risk for acute rejection after CsA withdrawal.

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Section: Discussionsupporting

confidence: 68%

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confidence: 99%

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Predictive Factors of Acute Rejection after Early Cyclosporine Withdrawal in Renal Transplant Recipients Who Receive Mycophenolate Mofetil

Hazzan¹,

Labalette²,

Copin³

et al. 2005

Journal of the American Society of Nephrology

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“…In addition, some small studies or anecdotal observations suggested that switching from cyclosporine to tacrolimus improved cardiovascular risk without impairing glucose metabolism (28). Complete withdrawal of either of the CNIs for the sake of improving metabolic parameters is clearly associated with a risk for rejection as has been observed in a number of trials (31)(32)(33). Conversion from one CNI to the other for the sake of metabolic benefits has not been tested adequately in large-scale, randomized trials.…”

Section: Role Of Immunosuppressionmentioning

confidence: 71%

Metabolic Syndrome in Kidney Transplantation

Hricik¹

2011

Clinical Journal of the American Society of Nephrology

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The metabolic syndrome is a constellation of clinical abnormalities related to insulin resistance and inflammation. The syndrome is now recognized as a risk factor for diabetes and cardiovascular disease in the general population. Recent studies suggest that the metabolic syndrome is common after kidney transplantation, also possibly being predictive of allograft loss and poor allograft function. The development or worsening of obesity plays a central role in the development of metabolic syndrome after kidney transplantation. Immunosuppression also plays an important role in the pathogenesis of the individual components of the metabolic syndrome. In fact, the overriding influence of immunosuppressive medications makes it unclear whether the metabolic syndrome has the same value in predicting outcomes as is true in the general population. However, recent studies suggest that the presence of metabolic syndrome before transplantation predicts the subsequent development of new-onset diabetes after transplantation, independent of other widely known risk factors. Aggressive management of the metabolic syndrome is warranted both before and after transplantation.

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“…Reversible acute rejections, the majority of which were mild, occurred in nine cyclosporine withdrawal patients versus two cyclosporine continuation patients (10.6% versus 2.4% of each group, P ϭ 0.03), with no graft loss. The lower rejection rate following CNI withdrawal reported by Abramowicz et al (41) may have been achieved because of the more gradual withdrawal of cyclosporine. The next two trials (42,43) were designed to evaluate the efficacy of a maintenance regimen of sirolimusprednisone following cyclosporine withdrawal.…”

Section: Trials With Cni-sparing Regimensmentioning

confidence: 84%

Immunosuppression Minimization

Vincenti

2003

Journal of the American Society of Nephrology

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Cyclosporine withdrawal from a mycophenolate mofetil???containing immunosuppressive regimen in stable kidney transplant recipients: a randomized, controlled study1,2

Abstract: Withdrawal of CsA from an MMF-containing triple-drug immunosuppressive regimen improves renal function and lipid profile at the cost of a modest increase in acute rejections, without graft loss.

Cited by 120 publications

References 0 publications

Predictive Factors of Acute Rejection after Early Cyclosporine Withdrawal in Renal Transplant Recipients Who Receive Mycophenolate Mofetil

Predictive Factors of Acute Rejection after Early Cyclosporine Withdrawal in Renal Transplant Recipients Who Receive Mycophenolate Mofetil

Metabolic Syndrome in Kidney Transplantation

Immunosuppression Minimization

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