Transplantation最新文献

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The Unmet Need for Solid Organ Transplantation in the US Pacific Islands: A Summary of Current Data and Challenges. 美国太平洋岛屿未满足的实体器官移植需求:当前数据和挑战的总结。
IF 5 2区 医学
Transplantation Pub Date : 2025-10-01 Epub Date: 2025-07-11 DOI: 10.1097/TP.0000000000005493
Dylan M Bush, Lung-Yi Lee, Paul Muña Aguon, Jon Yamaguchi, Dicken S C Ko
{"title":"The Unmet Need for Solid Organ Transplantation in the US Pacific Islands: A Summary of Current Data and Challenges.","authors":"Dylan M Bush, Lung-Yi Lee, Paul Muña Aguon, Jon Yamaguchi, Dicken S C Ko","doi":"10.1097/TP.0000000000005493","DOIUrl":"10.1097/TP.0000000000005493","url":null,"abstract":"","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":"1563-1567"},"PeriodicalIF":5.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144609699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and Therapeutic Outcomes of Adjuvant Immunotherapy With Autologous Cytokine-induced Killer Cells for Patients With Hepatocellular Carcinoma Beyond Milan Criteria After Liver Transplantation. 自体细胞因子诱导杀伤细胞辅助免疫治疗肝移植后非米兰标准肝癌患者的安全性和治疗效果
IF 5 2区 医学
Transplantation Pub Date : 2025-10-01 Epub Date: 2025-04-16 DOI: 10.1097/TP.0000000000005406
Geun Hong, Dong Kyu Han, Jinsoo Rhu, Suk Kyun Hong, YoungRok Choi, Nam-Joon Yi, Kwang-Woong Lee, Jongman Kim, Jaeseok Yang, Kyung-Suk Suh
{"title":"Safety and Therapeutic Outcomes of Adjuvant Immunotherapy With Autologous Cytokine-induced Killer Cells for Patients With Hepatocellular Carcinoma Beyond Milan Criteria After Liver Transplantation.","authors":"Geun Hong, Dong Kyu Han, Jinsoo Rhu, Suk Kyun Hong, YoungRok Choi, Nam-Joon Yi, Kwang-Woong Lee, Jongman Kim, Jaeseok Yang, Kyung-Suk Suh","doi":"10.1097/TP.0000000000005406","DOIUrl":"10.1097/TP.0000000000005406","url":null,"abstract":"<p><strong>Background: </strong>Adjuvant immunotherapy with autologous cytokine-induced killer (CIK) cells for hepatocellular carcinoma (HCC) remains understudied in liver transplant patients because of potential risks of acute rejection and diminished efficacy by immunosuppression.</p><p><strong>Methods: </strong>This study examined the safety and effectiveness of CIK therapy in patients with HCC exceeding the Milan criteria, treated at 2 Korean hospitals between 2019 and 2021. We analyzed clinical outcomes of 16 patients who underwent CIK therapy compared with 44 propensity-matched controls who did not receive CIK therapy. CIK cells were administered in 6 escalating doses, either 3 or 6 times over the course of weeks 4, 5, 6, 8, 10, and 12 posttransplantation.</p><p><strong>Results: </strong>CIK therapy was well-tolerated without significant treatment-related adverse reactions. Maximal tolerated dose of CIK cells was 10 × 10 9 , which had been repeated 6 times. The CIK group exhibited higher 2-y HCC recurrence-free (87.5% versus 62.9%, P  = 0.027) and patient survival (100% versus 81.5%, P  = 0.002) rates, with no significant difference in rejection-free survival rates (92.9% versus 95.0%, P  = 0.926) compared with the no-CIK group. Subgroup analysis showed that the CIK group in patients with high retreat scores, elevated R3-α-fetoprotein scores, and those beyond the University of California San Francisco criteria had improved HCC recurrence-free survival. Immunological evaluation showed elevated CD8 + T cells and polymorphonuclear myeloid-derived suppressor cells with transient increases in granzyme B and tumor necrosis factor-α levels in the CIK group.</p><p><strong>Conclusions: </strong>These findings advocate CIK therapy as a safe and effective, potential adjuvant treatment for HCC beyond Milan criteria after transplantation, supporting further validation trials.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":"e596-e608"},"PeriodicalIF":5.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144001288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Surgical Integration of Metanephros-bladder Composite Tissue Transplants in Adult Pigs. 成体猪后肾-膀胱复合组织移植的外科整合。
IF 5 2区 医学
Transplantation Pub Date : 2025-10-01 Epub Date: 2025-07-08 DOI: 10.1097/TP.0000000000005480
Yoshitaka Kinoshita, Shuichiro Yamanaka, Satomi Iwai, Haruki Kume, Takashi Yokoo, Eiji Kobayashi
{"title":"Surgical Integration of Metanephros-bladder Composite Tissue Transplants in Adult Pigs.","authors":"Yoshitaka Kinoshita, Shuichiro Yamanaka, Satomi Iwai, Haruki Kume, Takashi Yokoo, Eiji Kobayashi","doi":"10.1097/TP.0000000000005480","DOIUrl":"10.1097/TP.0000000000005480","url":null,"abstract":"","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":"e621-e622"},"PeriodicalIF":5.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144584974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Transplantation Awards: Recognizing Key Advancements and the Path Forward for Our Community. 移植奖:表彰我们社区的关键进步和前进道路。
IF 5 2区 医学
Transplantation Pub Date : 2025-10-01 Epub Date: 2025-04-21 DOI: 10.1097/TP.0000000000005414
Amy Cross, Paolo Cravedi
{"title":"The Transplantation Awards: Recognizing Key Advancements and the Path Forward for Our Community.","authors":"Amy Cross, Paolo Cravedi","doi":"10.1097/TP.0000000000005414","DOIUrl":"https://doi.org/10.1097/TP.0000000000005414","url":null,"abstract":"","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":"109 10","pages":"1561-1562"},"PeriodicalIF":5.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Perfusate Biomarker Comparison During Renal Hypothermic and Normothermic Machine Perfusion: Do These Techniques Provide Similar Insights? 肾低温和恒温机器灌注时灌注物生物标志物的比较:这些技术是否提供了类似的见解?
IF 5 2区 医学
Transplantation Pub Date : 2025-10-01 Epub Date: 2025-06-09 DOI: 10.1097/TP.0000000000005440
Tim L Hamelink, Baran Ogurlu, Chris L Jaynes, Veerle A Lantinga, Henri G D Leuvenink, Anna K Keller, Cyril Moers
{"title":"Perfusate Biomarker Comparison During Renal Hypothermic and Normothermic Machine Perfusion: Do These Techniques Provide Similar Insights?","authors":"Tim L Hamelink, Baran Ogurlu, Chris L Jaynes, Veerle A Lantinga, Henri G D Leuvenink, Anna K Keller, Cyril Moers","doi":"10.1097/TP.0000000000005440","DOIUrl":"10.1097/TP.0000000000005440","url":null,"abstract":"<p><strong>Background: </strong>Hypothermic machine perfusion (HMP) and normothermic machine perfusion (NMP) are increasingly used in renal transplantation. Both techniques enable pretransplant organ viability assessment through biomarker measurements in the perfusion solution. This study examines similarities and differences in biomarker release during HMP and NMP, focusing on well-established biomarkers alongside functional markers in porcine and discarded human donor kidneys.</p><p><strong>Methods: </strong>Discarded human donor kidneys (n = 25) underwent 4 h of oxygenated hypothermic machine perfusion (HMPO 2 ) and subsequently 4 h of NMP. Porcine kidneys were exposed to either minimal warm ischemia or 75 min of warm ischemia (n = 30 per group). Hereafter, kidneys were placed on HMPO 2 for 6 h followed by 6 h of NMP. Flow dynamics were recorded, and the biomarkers aspartate aminotransferase (ASAT), lactate dehydrogenase (LDH), N -acetyl-β-glucosaminidase, tissue inhibitor of metalloproteinases-2 (TIMP-2), and heart-type fatty acid-binding protein were measured longitudinally in the perfusates.</p><p><strong>Results: </strong>For human kidneys, we found moderate to strong correlations between ASAT, LDH, TIMP-2, and heart-type fatty acid-binding protein content measured during HMPO 2 and the same biomarkers during NMP. In porcine kidneys, clear distinctions between ischemically damaged and healthy kidneys were observed in flow dynamics and content of ASAT, LDH, and TIMP-2 during both HMPO 2 and NMP.</p><p><strong>Conclusions: </strong>Our findings suggest that biomarker release during HMPO 2 and NMP have similarities, indicating that some biomarkers might already be assessed during HMPO 2 . However, the predictive value of biomarkers in both techniques remains elusive. Additionally, NMP could provide important benefits over HMPO 2 , including functional assessment and reconditioning.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":"e554-e566"},"PeriodicalIF":5.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12453108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144249731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Minimally Invasive Donor Hepatectomy in Living Donor Liver Transplantation-Evidence of Benefit?: A Systematic Review and Meta-analysis of Current Literature. 微创供肝切除术在活体肝移植中的应用——有益的证据?当前文献的系统回顾与元分析。
IF 5 2区 医学
Transplantation Pub Date : 2025-10-01 Epub Date: 2025-06-09 DOI: 10.1097/TP.0000000000005438
Mariano Cesare Giglio, Gianluca Rompianesi, Gianluca Benassai, Giulia Filardi, Emanuela Maria Lo Bianco, Roberto Montalti, Roberto Ivan Troisi
{"title":"Minimally Invasive Donor Hepatectomy in Living Donor Liver Transplantation-Evidence of Benefit?: A Systematic Review and Meta-analysis of Current Literature.","authors":"Mariano Cesare Giglio, Gianluca Rompianesi, Gianluca Benassai, Giulia Filardi, Emanuela Maria Lo Bianco, Roberto Montalti, Roberto Ivan Troisi","doi":"10.1097/TP.0000000000005438","DOIUrl":"10.1097/TP.0000000000005438","url":null,"abstract":"<p><p>Minimally invasive donor hepatectomy (MIDH) has become a key innovation in living donor liver transplantation, offering potential advantages like reduced postoperative pain, faster recovery, less scarring, and related chronic pain. This study conducted a systematic review and meta-analysis to evaluate the benefits of MIDH compared with conventional open donor hepatectomy (ODH). A systematic search of Medline, Web of Science, and Scopus up to June 17, 2024, was performed to identify studies comparing outcomes of liver donors undergoing ODH, laparoscopic-assisted donor hepatectomy (LADH), pure laparoscopic donor hepatectomy (PLDH), or robotic-assisted donor hepatectomy (RADH) for any type of liver graft procurement. Meta-analyses of available data were performed using random-effect modeling. Thirty-seven nonrandomized comparative studies, published between 2006 and 2024, were included, including 4429 ODH, 479 LADH, 1351 PLDH, and 1136 RADH cases. LADH did not show significant benefits over ODH in the case of major hepatectomy. PLDH and RADH were associated with reduced hospital stay (-0.6 to -1.5 d) and decreased blood loss (-76 to -117 mL). Pure MIDH (PLDH and RADH) also showed a reduced risk of Clavien-Dindo grade I complications in case of major hepatectomy. In conclusion, MIDH, particularly PLDH and RADH, offers advantages over ODH, including reduced blood loss, shorter hospital stays, and fewer minor complications, especially for major hepatectomies.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":"1581-1590"},"PeriodicalIF":5.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144249730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Characterization of Spirometric Response to Standard-of-care Treatment in Lung Allograft Recipients With Bronchiolitis Obliterans and the Utility of Spirometric Criteria for Rescue Therapy: Implications for the Design of Risk-stratified Clinical Trials. 肺同种异体移植闭塞性细支气管炎受者对标准治疗的肺活量测定反应的特征和肺活量测定标准在抢救治疗中的应用:风险分层临床试验设计的意义
IF 5 2区 医学
Transplantation Pub Date : 2025-09-24 DOI: 10.1097/TP.0000000000005515
Derek E Byers, Ramsey Hachem, Chadi A Hage, Rajat Walia, Hilary Goldberg, Mrunal Patel, John Reynolds, Julia Klesney-Tait, Selim Arcasoy, Chetan Naik, Nicoe De Simone, Amena Usmani, Reda Girgis, Francis Cordova, Brian Keller, David Nunley, Jagadish Patil, Matthew Morrell, Elizabeth Lendermon, Howard Huang, Andres Pelaez, Amir Emtazoo, Keith Wille, Kevin Chan, Gordon Yung, Maher Baz, Shambhu Aryal, Suresh Vedantham, Mary Clare Derfler, Paul Commean, Keith Berman, Andrew Atkinson, Jeff Atkinson, Alexey Prokudin, John McCarthy, George J Despotis
{"title":"Characterization of Spirometric Response to Standard-of-care Treatment in Lung Allograft Recipients With Bronchiolitis Obliterans and the Utility of Spirometric Criteria for Rescue Therapy: Implications for the Design of Risk-stratified Clinical Trials.","authors":"Derek E Byers, Ramsey Hachem, Chadi A Hage, Rajat Walia, Hilary Goldberg, Mrunal Patel, John Reynolds, Julia Klesney-Tait, Selim Arcasoy, Chetan Naik, Nicoe De Simone, Amena Usmani, Reda Girgis, Francis Cordova, Brian Keller, David Nunley, Jagadish Patil, Matthew Morrell, Elizabeth Lendermon, Howard Huang, Andres Pelaez, Amir Emtazoo, Keith Wille, Kevin Chan, Gordon Yung, Maher Baz, Shambhu Aryal, Suresh Vedantham, Mary Clare Derfler, Paul Commean, Keith Berman, Andrew Atkinson, Jeff Atkinson, Alexey Prokudin, John McCarthy, George J Despotis","doi":"10.1097/TP.0000000000005515","DOIUrl":"https://doi.org/10.1097/TP.0000000000005515","url":null,"abstract":"<p><strong>Background: </strong>The spirometric response to standard-of-care (SOC) immunosuppressive therapy for the management of bronchiolitis obliterans syndrome (BOS) has been sparsely reported in the literature. Data from a Medicare-approved Registry were analyzed to characterize the effectiveness/durability of a wide range of SOC interventions to manage the decline of lung function and to validate the study spirometric criteria for initiation of rescue therapy.</p><p><strong>Methods: </strong>Lung transplant recipients with refractory BOS at 21 US collaborating centers were enrolled in the Registry. Data included both nonspirometric (eg, demographic, Immunosuppressive Regimens for management of BOS) and spirometric parameters (ie, FEV1 measurements and derived indices). The utility of study forced expiratory volume in 1 s (FEV1) criteria for treatment (ie, statistically significant rate of FEV1 decline >30 mL/mo) was evaluated by comparing the spirometric course between participants who met or did not meet this criterion.</p><p><strong>Results: </strong>Only 21% of participants treated with SOC therapy had >50% decrease (76 ± 25% decrease) in the rate of FEV1 decline. Although 51% of participants had a partial response (rate of FEV1 decline decreased on average 71%), 49% of participants had a substantial increase (mean increase 224%). The FEV1 criterion for treatment was able to identify 19% of participants (48/258) who achieved durable stabilization (ie, nonsignificant rate of FEV1 <30 mL/mo) with SOC therapy.</p><p><strong>Conclusions: </strong>Patients with BOS have a widely variable response to SOC therapy. Our findings support the use of FEV1 rate of decline to assess response to SOC therapy and to assure appropriate assignment of participants with refractory BOS to rescue therapy treatment cohorts.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":""},"PeriodicalIF":5.0,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145207706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Early Activation of the Complement System After Brain Death in Clinical Kidney Donation and Transplantation. 临床肾捐献和移植中脑死亡后补体系统的早期激活。
IF 5 2区 医学
Transplantation Pub Date : 2025-09-23 DOI: 10.1097/TP.0000000000005520
Laura W D Knijff, Mieke F van Essen, Sandra W van der Kooij, Daniëlle J van Gijlswijk-Janssen, John F Mulvey, Maria L Lo Faro, Rutger J Ploeg, Cees van Kooten
{"title":"Early Activation of the Complement System After Brain Death in Clinical Kidney Donation and Transplantation.","authors":"Laura W D Knijff, Mieke F van Essen, Sandra W van der Kooij, Daniëlle J van Gijlswijk-Janssen, John F Mulvey, Maria L Lo Faro, Rutger J Ploeg, Cees van Kooten","doi":"10.1097/TP.0000000000005520","DOIUrl":"https://doi.org/10.1097/TP.0000000000005520","url":null,"abstract":"<p><strong>Background: </strong>Brain death (BD) results in an inflammatory response, including complement activation. The clinical impact of prolonged BD duration on the graft-to-be is still unclear. We investigated how BD duration impacts complement activation levels, both systemically and locally within donor kidneys.</p><p><strong>Methods: </strong>EDTA plasma samples and kidney biopsies were obtained from the Quality in Organ Donation biobank (n = 120). Samples were routinely taken at 3 fixed points during BD management and donors were grouped according to short (≤14 h), medium (15-22 h), or long (≥23 h) duration of BD. ELISAs were used for quantification of complement in plasma, and immunohistochemistry was performed to determine complement activation at tissue level.</p><p><strong>Results: </strong>Plasma levels of C4d, Bb, C3c, and C5b-9 were significantly elevated compared with living donor samples taken at similar timepoint. Complement activation was already observed at the start of donor management and remained elevated. Prolonged BD duration was associated with reduced complement activation, with significantly lower levels of C4d and Bb, and trends toward lower C3c. Elevated levels of Bb were associated with increased delayed graft function (DGF), while increased C4d levels showed trends toward higher DGF and lower eGFR at 3 mo posttransplantation. Also, renal biopsies taken just before reperfusion, showed local complement activation, with more intense complement staining (C3d and C5b-9) in the vascular pole in kidneys that developed DGF.</p><p><strong>Conclusions: </strong>The complement system is already activated in BD donors early on during donor management. Prolonged BD duration was associated with reduced systemic complement activation. Increased systemic and local complement activation appears to negatively impact short-term kidney function.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":""},"PeriodicalIF":5.0,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145125984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Beyond Feasibility: Critical Steps Toward Drone-based Organ Transport. 超越可行性:迈向无人机器官运输的关键步骤。
IF 5 2区 医学
Transplantation Pub Date : 2025-09-23 DOI: 10.1097/TP.0000000000005527
Robson G Gilmour, Mekhola Hoff
{"title":"Beyond Feasibility: Critical Steps Toward Drone-based Organ Transport.","authors":"Robson G Gilmour, Mekhola Hoff","doi":"10.1097/TP.0000000000005527","DOIUrl":"https://doi.org/10.1097/TP.0000000000005527","url":null,"abstract":"","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":""},"PeriodicalIF":5.0,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145207666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and Tolerability of Sotagliflozin Among Kidney Transplant Recipients. 索他列净在肾移植受者中的安全性和耐受性。
IF 5 2区 医学
Transplantation Pub Date : 2025-09-23 DOI: 10.1097/TP.0000000000005503
Martina M McGrath, Finnian R Mc Causland, Brian L Claggett, Andrew S Levey, Karela Herrera-Enriquez, Marc A Pfeffer
{"title":"Safety and Tolerability of Sotagliflozin Among Kidney Transplant Recipients.","authors":"Martina M McGrath, Finnian R Mc Causland, Brian L Claggett, Andrew S Levey, Karela Herrera-Enriquez, Marc A Pfeffer","doi":"10.1097/TP.0000000000005503","DOIUrl":"https://doi.org/10.1097/TP.0000000000005503","url":null,"abstract":"<p><strong>Background: </strong>Sodium-glucose cotransporter inhibitors (SGLTi) slow chronic kidney disease progression and reduce kidney failure events. Kidney transplant recipients (KTRs) remain at high risk for these outcomes. SGLTi cause an initial and sustained decline in estimated glomerular filtration rate (eGFR) and have a higher risk of urogenital infection, both of which are major concerns for KTRs. We sought to (1) assess the reversibility of eGFR changes and (2) explore safety and tolerability using sotagliflozin, a dual SGLT1/2 inhibitor.</p><p><strong>Methods: </strong>We enrolled stable KTRs in a 16-wk open-label trial of sotagliflozin (12 wk on-drug and 4 wk off-drug) to assess the reversibility of eGFR changes. We assessed whether patient awareness of eGFR changes altered rates of withdrawal by randomizing participants to either (1) unlimited access to all study-related eGFR measurements or (2) limited access, that is, only when eGFR declined to >25% from baseline.</p><p><strong>Results: </strong>Forty patients were randomized. The mean age was 56 ± 15 y; the mean baseline eGFR was 64 ± 21 mL/min/1.73 m2. After 1 wk, change in eGFR from baseline was -4.6 ± 6.5 mL/min/1.73 m2 (-6.9 ± 9.5%). After washout, eGFR improved to -2.0 ± 6.3 mL/min/1.73 m2 (-2.4 ± 11%), with 73% of patients within 10% of baseline eGFR or higher. Limited versus unlimited access to eGFR measurements did not affect protocol completion (P = 0.34). Sotagliflozin was generally well tolerated, but 4 patients were withdrawn due to adverse events, with none due to decline in eGFR.</p><p><strong>Conclusions: </strong>Among stable KTRs, sotagliflozin caused an initial decline in eGFR of similar magnitude to patients with chronic kidney disease, with reversibility upon withdrawal. Access to follow-up eGFR measurements did not affect study adherence.</p>","PeriodicalId":23316,"journal":{"name":"Transplantation","volume":" ","pages":""},"PeriodicalIF":5.0,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145131870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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