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Tacrolimus 4‐hour monitoring in liver transplant patients is non‐inferior to trough monitoring: The randomized controlled FK04 trial
Background After liver transplantation (LT), tacrolimus and ciclosporin treatment can lead to, partially concentration‐dependent, chronic kidney disease. Monitoring ciclosporin with two‐hour levels reduced overexposure and led to better renal function than trough‐monitoring (C0). For tacrolimus, a 4...
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Published in: | Clinical transplantation 2022-12, Vol.36 (12), p.e14829-n/a |
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container_start_page | e14829 |
container_title | Clinical transplantation |
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creator | Ruijter, Bastian N. Tushuizen, Maarten E. Moes, Dirk J. A. R. Klerk, Babs M. de Hoek, Bart van |
description | Background
After liver transplantation (LT), tacrolimus and ciclosporin treatment can lead to, partially concentration‐dependent, chronic kidney disease. Monitoring ciclosporin with two‐hour levels reduced overexposure and led to better renal function than trough‐monitoring (C0). For tacrolimus, a 4‐hour level (C4) can give a reasonable approximation of total drug exposure. We evaluated whether monitoring tacrolimus in stable patients after LT by C4 was superior to C0 regarding renal function, rejection and metabolic parameters.
Methods
This open label randomized controlled trial compared C4 monitoring of tacrolimus BID (Prograft) to trough (C0) monitoring in stable LT recipients. The target range for C4 of 7.8–16 ng/ml was calculated to be comparable with target C0 of 4–8 ng/ml. Primary endpoint was the effect on renal function and secondary endpoints were the occurrence of treated biopsy‐proven acute rejection, blood pressure and metabolic parameters, during 3 months of follow‐up.
Results
Fifty patients were randomized to C0 (n = 25) or C4 (n = 25) monitoring. There was no difference in renal function between the C0 and the C4 group (p = .98 and p = .13 for CG and MDRD at 3 months). Also, the amount of proteinuria was similar (p = .59). None of the patients suffered from graft loss or was treated for rejection. Metabolic parameters did not differ between the two groups.
Conclusion
Tacrolimus 4‐hour monitoring in stable LT patients is not superior to trough monitoring, regarding the effect on renal function, but is safe for use to facilitate tacrolimus monitoring in an afternoon outpatient clinic. |
doi_str_mv | 10.1111/ctr.14829 |
format | article |
fullrecord | <record><control><sourceid>wiley_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10078353</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>CTR14829</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4169-5a210b27f510dcd89a7c28d31dbd129f5a4b9ec823a1b23a595d2d367336025b3</originalsourceid><addsrcrecordid>eNp1kc1OGzEUha0K1ATaRV8AecsixD_jmTEbVEUEEEiVqnRtecaexMhjR_YEFFYsWfYZ-yTcEkB0US_sK9_vHMv3IPSNkhMKa9oO6YQWNZOf0JhyKSeEULaHxkQSBnXJR-gg51u4LWkpPqMRL6nkohJj9LTQbYre9ZuMiz-Pv1dxk3AfgxticmGJXcDe3dmEh6RDXnsdBrzWg7NhyNhlHGIAlQudTS4CFQGMm-Xqg8cpXqwsBrmJvXuwBrcxAOQ9lPNrUoDCaf8F7XfaZ_v19TxEv-bni9nl5ObHxdXs-82kLWgpJ0IzShpWdYIS05pa6qplteHUNIYy2QldNNK2NeOaNrAJKQwzvKw4LwkTDT9EZzvf9abprWnhI0l7tU6u12mronbq305wK7WMd4oSUtVccHA43jnA4HJOtnsXU6L-5qEgD_WSB7BHH197J98CAGC6A-6dt9v_O6nZ4ufO8hnXX5rI</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Tacrolimus 4‐hour monitoring in liver transplant patients is non‐inferior to trough monitoring: The randomized controlled FK04 trial</title><source>Wiley-Blackwell Read & Publish Collection</source><creator>Ruijter, Bastian N. ; Tushuizen, Maarten E. ; Moes, Dirk J. A. R. ; Klerk, Babs M. de ; Hoek, Bart van</creator><creatorcontrib>Ruijter, Bastian N. ; Tushuizen, Maarten E. ; Moes, Dirk J. A. R. ; Klerk, Babs M. de ; Hoek, Bart van</creatorcontrib><description>Background
After liver transplantation (LT), tacrolimus and ciclosporin treatment can lead to, partially concentration‐dependent, chronic kidney disease. Monitoring ciclosporin with two‐hour levels reduced overexposure and led to better renal function than trough‐monitoring (C0). For tacrolimus, a 4‐hour level (C4) can give a reasonable approximation of total drug exposure. We evaluated whether monitoring tacrolimus in stable patients after LT by C4 was superior to C0 regarding renal function, rejection and metabolic parameters.
Methods
This open label randomized controlled trial compared C4 monitoring of tacrolimus BID (Prograft) to trough (C0) monitoring in stable LT recipients. The target range for C4 of 7.8–16 ng/ml was calculated to be comparable with target C0 of 4–8 ng/ml. Primary endpoint was the effect on renal function and secondary endpoints were the occurrence of treated biopsy‐proven acute rejection, blood pressure and metabolic parameters, during 3 months of follow‐up.
Results
Fifty patients were randomized to C0 (n = 25) or C4 (n = 25) monitoring. There was no difference in renal function between the C0 and the C4 group (p = .98 and p = .13 for CG and MDRD at 3 months). Also, the amount of proteinuria was similar (p = .59). None of the patients suffered from graft loss or was treated for rejection. Metabolic parameters did not differ between the two groups.
Conclusion
Tacrolimus 4‐hour monitoring in stable LT patients is not superior to trough monitoring, regarding the effect on renal function, but is safe for use to facilitate tacrolimus monitoring in an afternoon outpatient clinic.</description><identifier>ISSN: 0902-0063</identifier><identifier>EISSN: 1399-0012</identifier><identifier>DOI: 10.1111/ctr.14829</identifier><identifier>PMID: 36193575</identifier><language>eng</language><publisher>Denmark: John Wiley and Sons Inc</publisher><subject>calcineurin inhibitor ; Cyclosporine ; Drug Monitoring ; Graft Rejection - drug therapy ; Graft Rejection - etiology ; graft survival ; Humans ; Immunosuppressive Agents - therapeutic use ; Kidney Transplantation ; Liver Transplantation ; Original ; renal function ; Tacrolimus - therapeutic use ; therapeutic drug monitoring</subject><ispartof>Clinical transplantation, 2022-12, Vol.36 (12), p.e14829-n/a</ispartof><rights>2022 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2022 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4169-5a210b27f510dcd89a7c28d31dbd129f5a4b9ec823a1b23a595d2d367336025b3</citedby><cites>FETCH-LOGICAL-c4169-5a210b27f510dcd89a7c28d31dbd129f5a4b9ec823a1b23a595d2d367336025b3</cites><orcidid>0000-0001-6527-764X ; 0000-0003-4737-4088</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36193575$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ruijter, Bastian N.</creatorcontrib><creatorcontrib>Tushuizen, Maarten E.</creatorcontrib><creatorcontrib>Moes, Dirk J. A. R.</creatorcontrib><creatorcontrib>Klerk, Babs M. de</creatorcontrib><creatorcontrib>Hoek, Bart van</creatorcontrib><title>Tacrolimus 4‐hour monitoring in liver transplant patients is non‐inferior to trough monitoring: The randomized controlled FK04 trial</title><title>Clinical transplantation</title><addtitle>Clin Transplant</addtitle><description>Background
After liver transplantation (LT), tacrolimus and ciclosporin treatment can lead to, partially concentration‐dependent, chronic kidney disease. Monitoring ciclosporin with two‐hour levels reduced overexposure and led to better renal function than trough‐monitoring (C0). For tacrolimus, a 4‐hour level (C4) can give a reasonable approximation of total drug exposure. We evaluated whether monitoring tacrolimus in stable patients after LT by C4 was superior to C0 regarding renal function, rejection and metabolic parameters.
Methods
This open label randomized controlled trial compared C4 monitoring of tacrolimus BID (Prograft) to trough (C0) monitoring in stable LT recipients. The target range for C4 of 7.8–16 ng/ml was calculated to be comparable with target C0 of 4–8 ng/ml. Primary endpoint was the effect on renal function and secondary endpoints were the occurrence of treated biopsy‐proven acute rejection, blood pressure and metabolic parameters, during 3 months of follow‐up.
Results
Fifty patients were randomized to C0 (n = 25) or C4 (n = 25) monitoring. There was no difference in renal function between the C0 and the C4 group (p = .98 and p = .13 for CG and MDRD at 3 months). Also, the amount of proteinuria was similar (p = .59). None of the patients suffered from graft loss or was treated for rejection. Metabolic parameters did not differ between the two groups.
Conclusion
Tacrolimus 4‐hour monitoring in stable LT patients is not superior to trough monitoring, regarding the effect on renal function, but is safe for use to facilitate tacrolimus monitoring in an afternoon outpatient clinic.</description><subject>calcineurin inhibitor</subject><subject>Cyclosporine</subject><subject>Drug Monitoring</subject><subject>Graft Rejection - drug therapy</subject><subject>Graft Rejection - etiology</subject><subject>graft survival</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Kidney Transplantation</subject><subject>Liver Transplantation</subject><subject>Original</subject><subject>renal function</subject><subject>Tacrolimus - therapeutic use</subject><subject>therapeutic drug monitoring</subject><issn>0902-0063</issn><issn>1399-0012</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp1kc1OGzEUha0K1ATaRV8AecsixD_jmTEbVEUEEEiVqnRtecaexMhjR_YEFFYsWfYZ-yTcEkB0US_sK9_vHMv3IPSNkhMKa9oO6YQWNZOf0JhyKSeEULaHxkQSBnXJR-gg51u4LWkpPqMRL6nkohJj9LTQbYre9ZuMiz-Pv1dxk3AfgxticmGJXcDe3dmEh6RDXnsdBrzWg7NhyNhlHGIAlQudTS4CFQGMm-Xqg8cpXqwsBrmJvXuwBrcxAOQ9lPNrUoDCaf8F7XfaZ_v19TxEv-bni9nl5ObHxdXs-82kLWgpJ0IzShpWdYIS05pa6qplteHUNIYy2QldNNK2NeOaNrAJKQwzvKw4LwkTDT9EZzvf9abprWnhI0l7tU6u12mronbq305wK7WMd4oSUtVccHA43jnA4HJOtnsXU6L-5qEgD_WSB7BHH197J98CAGC6A-6dt9v_O6nZ4ufO8hnXX5rI</recordid><startdate>202212</startdate><enddate>202212</enddate><creator>Ruijter, Bastian N.</creator><creator>Tushuizen, Maarten E.</creator><creator>Moes, Dirk J. A. R.</creator><creator>Klerk, Babs M. de</creator><creator>Hoek, Bart van</creator><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6527-764X</orcidid><orcidid>https://orcid.org/0000-0003-4737-4088</orcidid></search><sort><creationdate>202212</creationdate><title>Tacrolimus 4‐hour monitoring in liver transplant patients is non‐inferior to trough monitoring: The randomized controlled FK04 trial</title><author>Ruijter, Bastian N. ; Tushuizen, Maarten E. ; Moes, Dirk J. A. R. ; Klerk, Babs M. de ; Hoek, Bart van</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4169-5a210b27f510dcd89a7c28d31dbd129f5a4b9ec823a1b23a595d2d367336025b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>calcineurin inhibitor</topic><topic>Cyclosporine</topic><topic>Drug Monitoring</topic><topic>Graft Rejection - drug therapy</topic><topic>Graft Rejection - etiology</topic><topic>graft survival</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Kidney Transplantation</topic><topic>Liver Transplantation</topic><topic>Original</topic><topic>renal function</topic><topic>Tacrolimus - therapeutic use</topic><topic>therapeutic drug monitoring</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ruijter, Bastian N.</creatorcontrib><creatorcontrib>Tushuizen, Maarten E.</creatorcontrib><creatorcontrib>Moes, Dirk J. A. R.</creatorcontrib><creatorcontrib>Klerk, Babs M. de</creatorcontrib><creatorcontrib>Hoek, Bart van</creatorcontrib><collection>Open Access: Wiley-Blackwell Open Access Journals</collection><collection>Wiley Online Library Free Backfiles</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ruijter, Bastian N.</au><au>Tushuizen, Maarten E.</au><au>Moes, Dirk J. A. R.</au><au>Klerk, Babs M. de</au><au>Hoek, Bart van</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tacrolimus 4‐hour monitoring in liver transplant patients is non‐inferior to trough monitoring: The randomized controlled FK04 trial</atitle><jtitle>Clinical transplantation</jtitle><addtitle>Clin Transplant</addtitle><date>2022-12</date><risdate>2022</risdate><volume>36</volume><issue>12</issue><spage>e14829</spage><epage>n/a</epage><pages>e14829-n/a</pages><issn>0902-0063</issn><eissn>1399-0012</eissn><abstract>Background
After liver transplantation (LT), tacrolimus and ciclosporin treatment can lead to, partially concentration‐dependent, chronic kidney disease. Monitoring ciclosporin with two‐hour levels reduced overexposure and led to better renal function than trough‐monitoring (C0). For tacrolimus, a 4‐hour level (C4) can give a reasonable approximation of total drug exposure. We evaluated whether monitoring tacrolimus in stable patients after LT by C4 was superior to C0 regarding renal function, rejection and metabolic parameters.
Methods
This open label randomized controlled trial compared C4 monitoring of tacrolimus BID (Prograft) to trough (C0) monitoring in stable LT recipients. The target range for C4 of 7.8–16 ng/ml was calculated to be comparable with target C0 of 4–8 ng/ml. Primary endpoint was the effect on renal function and secondary endpoints were the occurrence of treated biopsy‐proven acute rejection, blood pressure and metabolic parameters, during 3 months of follow‐up.
Results
Fifty patients were randomized to C0 (n = 25) or C4 (n = 25) monitoring. There was no difference in renal function between the C0 and the C4 group (p = .98 and p = .13 for CG and MDRD at 3 months). Also, the amount of proteinuria was similar (p = .59). None of the patients suffered from graft loss or was treated for rejection. Metabolic parameters did not differ between the two groups.
Conclusion
Tacrolimus 4‐hour monitoring in stable LT patients is not superior to trough monitoring, regarding the effect on renal function, but is safe for use to facilitate tacrolimus monitoring in an afternoon outpatient clinic.</abstract><cop>Denmark</cop><pub>John Wiley and Sons Inc</pub><pmid>36193575</pmid><doi>10.1111/ctr.14829</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-6527-764X</orcidid><orcidid>https://orcid.org/0000-0003-4737-4088</orcidid><oa>free_for_read</oa></addata></record> |
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source | Wiley-Blackwell Read & Publish Collection |
subjects | calcineurin inhibitor Cyclosporine Drug Monitoring Graft Rejection - drug therapy Graft Rejection - etiology graft survival Humans Immunosuppressive Agents - therapeutic use Kidney Transplantation Liver Transplantation Original renal function Tacrolimus - therapeutic use therapeutic drug monitoring |
title | Tacrolimus 4‐hour monitoring in liver transplant patients is non‐inferior to trough monitoring: The randomized controlled FK04 trial |
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