scholarly journals Renal Function and NODM inDe NovoRenal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Laurence Chan ◽  
Amado Andres ◽  
Suphamai Bunnapradist ◽  
Kristene Gugliuzza ◽  
Ravi Parasuraman ◽  
...  

Information is lacking concerning concomitant administration of enteric-coated mycophenolate sodium with tacrolimus (EC-MPS+Tac) in renal transplant recipients (RTxR). In this 6-month, prospective, open-label, multicenter study,de novoRTxR were randomized (1 : 1) to low-dose (LD) or standard-dose (SD) Tac with basiliximab, EC-MPS 720 mg bid, and steroids. Primary objective was to compare renal function at 6-month posttransplantation. Secondary objectives were to compare the incidences of biopsy-proven acute rejection (BPAR), graft loss and death, and new-onset diabetes mellitus (NODM). 292 patients (LDn=151, SDn=141) were included. Mean Tac levels were at the low end of the target range in standard-exposure patients (SD,n=141) and exceeded target range in low-exposure patients (LD = 151) throughout the study. There was no significant difference in mean glomerular filtration rate (GFR) between treatments (ITT-population: 63.6 versus 61.0 mL/min). Incidence of BPAR was similar (10.6% versus 9.9%). NODM was significantly less frequent in LD Tac (17% versus 31%;P=0.02); other adverse effects (AEs) were comparable. EC-MPS+Tac (LD/SD) was efficacious and well tolerated with well-preserved renal function. No renal function benefits were demonstrated, possibly related to poor adherence to reduced Tac exposure.

2020 ◽  
Vol 35 (3) ◽  
pp. 512-519 ◽  
Author(s):  
Manuela Yepes-Calderón ◽  
Camilo G Sotomayor ◽  
Rijk O B Gans ◽  
Stefan P Berger ◽  
Henri G D Leuvenink ◽  
...  

Abstract Background In renal transplant recipients (RTRs), cardiovascular mortality is the most common cause of long-term renal graft loss. Oxidative stress (OS) has been associated with cardiovascular disease and is known to be enhanced in RTRs. We aimed to prospectively investigate whether the concentration of the OS biomarker malondialdehyde (MDA) is associated with long-term risk of cardiovascular mortality in a large cohort of RTRs. Methods The plasma MDA concentration was measured using the thiobarbituric acid reaction assay in 604 extensively phenotyped RTRs with a functioning allograft for ≥1 year. The association between MDA and cardiovascular mortality was assessed using Cox proportional hazard regression analyses in the overall cohort and within subgroups according to significant effect modifiers. Results Median circulating MDA concentration at baseline was 5.38 [interquartile range (IQR) 4.31–6.45] μmol/L. During a follow-up period of 6.4 (IQR 5.6–6.8) years, 110 (18%) RTRs died, with 40% of deaths due to cardiovascular causes. MDA concentration was significantly associated with the risk for cardiovascular mortality {hazard ratio [HR] 1.31 [95% confidence interval (CI) 1.03–1.67] per 1-SD increment}, independent of adjustment for potential confounders, including renal function, immunosuppressive therapy, smoking status and blood pressure. The association between MDA concentration and the risk for cardiovascular mortality was stronger in RTRs with relatively lower plasma ascorbic acid concentrations [≤42.5 µmol/L; HR 1.79 (95% CI 1.30–2.48) per 1-SD increment] or relatively lower estimated glomerular filtration rates [≤45 mL/min/1.73 m2; HR 2.09 (95% CI 1.45–3.00) per 1-SD increment]. Conclusions Circulating MDA concentration is independently associated with long-term risk for cardiovascular mortality, particularly in RTRs with relatively lower ascorbic acid concentrations or renal function. Further studies are warranted to elucidate whether OS-targeted interventions could decrease cardiovascular mortality in RTRs.


2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Andreas Zuckermann ◽  
Shoei-Shen Wang ◽  
Heather Ross ◽  
Maria Frigerio ◽  
Howard J. Eisen ◽  
...  

A six-month, multicenter, randomized, open-label study was undertaken to determine whether renal function is improved using reduced-exposure cyclosporine (CsA) versus standard-exposure CsA in 199de novoheart transplant patients receiving everolimus and steroids ± induction therapy. Mean C2levels were at the low end of the target range in standard-exposure patients (n=100) and exceeded target range in reduced-exposure patients (n=99) throughout the study. Mean serum creatinine at Month 6 (the primary endpoint) was141.0±53.1 μmol/L in standard-exposure patients versus130.1±53.7 μmol/L in reduced-exposure patients (P=0.093). The incidence of biopsy-proven acute rejection ≥3A at Month 6 was 21.0% (21/100) in the standard-exposure group and 16.2% (16/99) in the reduced-exposure group (n.s.). Adverse events and infections were similar between treatment groups. Thus, everolimus with reduced-exposure CsA resulted in comparable efficacy compared to standard-exposure CsA. No renal function benefits were demonstrated; that is possibly related to poor adherence to reduced CsA exposure.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Sara Mahdibeiraghdar ◽  
Abbas Ghazanfar ◽  
Sarah Heap ◽  
Abul Siddiky ◽  
Claire Fraser Taylor ◽  
...  

Abstract Aims The aim of this audit was to establish the impact of COVID-19 on the outcomes of renal transplant recipients in the post-transplant period at our centre, through the 2020 calendar year. Methods Living donor and deceased donor renal transplant recipients in the period of interest were identified and any complications or adverse outcomes were reviewed and compared to outcome data from the previous year. Results A total of 88 renal transplants were performed in 2020. Fifty-five cases were performed after reopening the Unit. Five patients tested positive for COVID-19 in the post-transplant period. One patient was admitted to the Intensive Care Unit and subsequently died from related complications. Another patient suffered from internal jugular vein thrombosis shortly after testing positive and could be attributed to the hypercoagulable state post-infection. A total of 4 deaths and 1 graft loss were recorded within 2020. This compares to 1 death, 2 graft losses and 1 primary non-function in 172 transplants in 2019. Of the 4 deaths, one was directly linked to COVID-19. The other 3 deaths could be indirectly linked to the disruptions that were made in the healthcare system during this period in adapting to the pandemic. Conclusions It was anticipated that COVID-19 will directly and indirectly affect patient outcomes from surgery during this period. This was clearly seen at this Unit, with mortality rates having increased almost eight-fold in the post-transplant period compared to the same period in the previous year. However, no significant difference was seen with graft losses.


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