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| 2. |
- Glasbey, JC, et al.
(författare)
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- 2021
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swepub:Mat__t
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| 3. |
- Frunza, Mihaela, et al.
(författare)
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Dealing With Public Solicitation of Organs From Living Donors-An ELPAT View
- 2015
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Ingår i: Transplantation. - 0041-1337 .- 1534-6080. ; 99:10, s. 2210-4
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Tidskriftsartikel (refereegranskat)abstract
- Although transplant professionals have initially been reluctant to perform transplants after public solicitation of organs from living donors, nowadays these transplants are increasingly being performed and reported. After clarifying the existing terminology, we elaborate an operational definition of public solicitation that is consistent with the Ethical, Legal, and Psychosocial Aspects of Transplantation classification for living organ donation. Our aim is to critically assess this phenomenon, from a legal, moral, and practical perspective, and to offer some recommendations. From a legal point of view, we analyze the current situation in the Europe and the United States. From a moral perspective, we evaluate the various arguments used in the literature, both in favor and against. Finally, we offer a set of recommendations aimed at maximizing the organ donor pool while safeguarding the interests of potential living donors.
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| 4. |
- Kraemer, Bernhard K., et al.
(författare)
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Tacrolimus-Based, Steroid-Free Regimens in Renal Transplantation : 3-Year Follow-Up of the ATLAS Trial
- 2012
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Ingår i: Transplantation. - 0041-1337 .- 1534-6080. ; 94:5, s. 492-498
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Tidskriftsartikel (refereegranskat)abstract
- Background. Long-term use of corticosteroids is associated with considerable morbidity, including cardiovascular and metabolic adverse effects. Methods. This study evaluated the long-term efficacy and safety of two steroid-free regimens compared with a triple immunosuppressive therapy in renal transplant recipients. This was a 3-year follow-up to a 6-month, open-label, randomized, multicenter study. Results. Data from 3 years were available for 421 (93.3%) of 451 patients in the original intent-to-treat population (143 tacrolimus/basiliximab [Tac/Bas], 139 tacrolimus/mycophenolate mofetil [Tac/MMF], and 139 tacrolimus/MMF/steroids [triple therapy]). In the time interval from 6 months to 3 years after transplantation, the incidence of biopsy-proven acute rejection was low and similar (Tac/Bas, 2.1%; Tac/MMF, 2.2%; triple therapy, 2.2%); Most rejection episodes occurred during the first 6 months of the study. Graft survival was high (Kaplan-Meier estimates: 92.7%, 92.5%, and 92.5%), as was patient survival (93.1%, 96.4%, and 97.0%). There were 10 graft losses (n=2, 4, and 4) and 12 patient deaths (n=5, 2, and 5). Renal function was well preserved throughout the study and similar between groups. There was a trend toward improved cardiovascular risk factors in the Tac/Bas group, including reduced total and low-density lipoprotein cholesterol and lower new-onset insulin use. There were no between-group differences in the incidence or type of adverse events. Conclusion. Higher rates of acute rejection early in treatment were seen with the steroid-free regimens, but this did not translate into poorer long-term outcomes, such as graft and patient survival and renal function. A trend for a more favorable cardiovascular risk profile was observed for steroid-free immunosuppression with Tac/Bas.
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| 5. |
- Krämer, Bernhard K., et al.
(författare)
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Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation : one year observational results
- 2010
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Ingår i: Clinical Transplantation. - : Wiley. - 0902-0063 .- 1399-0012. ; 24:1, s. E1-E9
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Tidskriftsartikel (refereegranskat)abstract
- Side effects of steroid use have led to efforts to minimize their use in transplantation. Two corticosteroid-free regimens were compared with a triple immunosuppressive therapy. Data from the original intent-to-treat (ITT) population (153 tacrolimus/basiliximab [Tac/Bas], 151 tacrolimus/MMF [Tac/MMF], and 147 tacrolimus/MMF/steroids [control]) were analyzed in a 12-month follow-up. Percentage of graft survival were 92.8%, 95.4%, and 95.9% (KM estimates 89.9%, 95.3%, 95.9%), percentage of surviving patients were 98.7%, 98.0%, and 100% (KM estimates 95.9%, 92.8%, and 100%). During months 7-12, graft loss occurred in 3 Tac/Bas, 2 Tac/MMF, and zero control patients, patient deaths in 1 Tac/Bas, 2 Tac/MMF, and zero control, and biopsy-proven acute rejection episodes in 4 Tac/Bas, 3 Tac/MMF, and zero control. Mean serum creatinine at month 12 was 141.9 +/- 69.6 muM, 144.0 +/- 82.1 muM, and 134.5 +/- 71.2 muM (ns). New-onset insulin use in previously non-diabetic patients at month 12 was 1/138, 6/127, and 4/126. Patient and graft survival as well as renal function at 12 months were not different between patient groups, despite considerably higher rates of acute rejection occurring within the first six months after transplantation in both steroid-free patient groups. Tac/Bas therapy might offer benefits in terms of a trend for a more favorable cardiovascular risk profile.
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| 6. |
- Pascual, Julio, et al.
(författare)
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Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.
- 2018
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Ingår i: Journal of the American Society of Nephrology. - 1046-6673 .- 1533-3450. ; 29:7, s. 1979-1991
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Tidskriftsartikel (refereegranskat)abstract
- Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation.Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR<50 ml/min per 1.73 m2 at post-transplant month 12 using a 10% noninferiority margin.Results In the intent-to-treat population (everolimus n=1022, MPA n=1015), the primary end point incidence was 48.2% (493) with everolimus and 45.1% (457) with MPA (difference 3.2%; 95% confidence interval, -1.3% to 7.6%). Similar between-treatment differences in incidence were observed in the subgroups of patients who received tacrolimus or cyclosporine. Treated biopsy-proven acute rejection, graft loss, or death at post-transplant month 12 occurred in 14.9% and 12.5% of patients treated with everolimus and MPA, respectively (difference 2.3%; 95% confidence interval, -1.7% to 6.4%). De novo donor-specific antibody incidence at 12 months and antibody-mediated rejection rate did not differ between arms. Cytomegalovirus (3.6% versus 13.3%) and BK virus infections (4.3% versus 8.0%) were less frequent in the everolimus arm than in the MPA arm. Overall, 23.0% and 11.9% of patients treated with everolimus and MPA, respectively, discontinued the study drug because of adverse events.Conclusions In kidney transplant recipients at mild-to-moderate immunologic risk, everolimus was noninferior to MPA for a binary composite end point assessing immunosuppressive efficacy and preservation of graft function.
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| 7. |
- Tedesco-Silva, Helio, et al.
(författare)
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Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants : An Analysis From the Randomized TRANSFORM Study
- 2019
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Ingår i: Transplantation. - 0041-1337 .- 1534-6080. ; 103:9, s. 1953-1963
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The safety profiles of standard therapy versus everolimus with reduced-exposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients have not been compared in detail.METHODS: TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced-exposure CNI (N = 1014) or mycophenolic acid (MPA) with standard-exposure CNI (N = 1012), both with induction and corticosteroids.RESULTS: Within the safety population (everolimus 1014, MPA 1012), adverse events with a suspected relation to study drug occurred in 62.9% versus 59.2% of patients given everolimus or MPA, respectively (P = 0.085). Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia, and wound healing complications were more frequent with everolimus, whereas diarrhea, nausea, vomiting, leukopenia, tremor, and insomnia were more frequent in the MPA group. The incidence of viral infections (17.2% versus 29.2%; P < 0.001), cytomegalovirus (CMV) infections (8.1% versus 20.1%; P < 0.001), CMV syndrome (13.6% versus 23.0%, P = 0.044), and BK virus (BKV) infections (4.3% versus 8.0%, P < 0.001) were less frequent with everolimus. CMV infection was less common with everolimus versus MPA after adjusting for prophylaxis therapy in the D+/R- subgroup (P < 0.001). Study drug was discontinued more frequently due to rejection or impaired healing with everolimus, and more often due to BKV infection or BKV nephropathy with MPA.CONCLUSIONS: De novo everolimus with reduced-exposure CNI yielded a comparable incidence, though a distinctly different pattern, of adverse events versus current standard of care. Both regimens are safe and effective, yet their distinct profiles may enable tailoring for individual kidney transplant recipients.
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| 8. |
- Van Assche, Kristof, et al.
(författare)
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The Relevance of Directive 2010/53/EU for Living Organ Donation Practice: An ELPAT View
- 2015
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Ingår i: Transplantation. - 0041-1337 .- 1534-6080. ; 99:10, s. 2215-22
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Tidskriftsartikel (refereegranskat)abstract
- With the recent transposition of Directive 2010/53/EU into the transplant regulation of EU Member States, the time is right to have a closer look at its implications for living organ donation practice. We first discuss the relevance of the Action Plan which forms the basis for the policy of the European Commission in the field of organ donation and transplantation. We then analyze the impact of Directive 2010/53/EU which was adopted to support the implementation of the Priority Actions set out in the Action Plan. We more specifically focus on the obligations of transplant centers engaged in living organ donation and highlight their significance for clinical practice. Finally, we point out some strengths and weaknesses of the Directive in addressing living organ donation.
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