Disposition of Recombinant Human Interleukin-10 in Subjects with Various Degrees of Renal Function
The pharmacokinetics of intravenously administered recombinant human interleukin‐10 (rHuIL‐10) were evaluated in 18 subjects with creatinine clearances (Clcr) between 2.7 and 116.7 mL/min/1.73m2. Serum samples for rHuIL‐10 were obtained over a 48‐hour period after a single 25 μg/kg IV bolus infusion...
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| Veröffentlicht in: | Journal of clinical pharmacology 1999-10, Vol.39 (10), p.1015-1020 |
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| container_title | Journal of clinical pharmacology |
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| creator | Andersen, Scott R. Lambrecht, Lawrence J. Swan, Suzanne K. Cutler, David L. Radwanski, Elaine Affrime, Melton B. Garaud, Jean-Jacques |
| description | The pharmacokinetics of intravenously administered recombinant human interleukin‐10 (rHuIL‐10) were evaluated in 18 subjects with creatinine clearances (Clcr) between 2.7 and 116.7 mL/min/1.73m2. Serum samples for rHuIL‐10 were obtained over a 48‐hour period after a single 25 μg/kg IV bolus infusion. AUC, total body clearance (Clp), and steady‐state volume of distribution (Vdss) were derived by compartmental methods. Analysis of serum concentrations showed statistically significant group differences for log‐transformed AUC and original scale Clp (p < 0.01). The AUC and effective half‐life increased, while the mean Clp of rHuIL‐10 decreased as renal function declined. A linear relationship between AUC and Clcr as well as Clp and Clcr demonstrates that the disposition of rHuIL‐10 is altered in subjects with renal insufficiency. No serious adverse events were noted. |
| doi_str_mv | 10.1177/00912709922011773 |
| format | Article |
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Serum samples for rHuIL‐10 were obtained over a 48‐hour period after a single 25 μg/kg IV bolus infusion. AUC, total body clearance (Clp), and steady‐state volume of distribution (Vdss) were derived by compartmental methods. Analysis of serum concentrations showed statistically significant group differences for log‐transformed AUC and original scale Clp (p < 0.01). The AUC and effective half‐life increased, while the mean Clp of rHuIL‐10 decreased as renal function declined. A linear relationship between AUC and Clcr as well as Clp and Clcr demonstrates that the disposition of rHuIL‐10 is altered in subjects with renal insufficiency. No serious adverse events were noted.</description><identifier>ISSN: 0091-2700</identifier><identifier>EISSN: 1552-4604</identifier><identifier>DOI: 10.1177/00912709922011773</identifier><identifier>PMID: 10516935</identifier><identifier>CODEN: JCPCBR</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Area Under Curve ; Biological and medical sciences ; Creatinine - urine ; Data Interpretation, Statistical ; Fever - chemically induced ; Flushing - chemically induced ; Headache - chemically induced ; Humans ; Immunomodulators ; Interleukin-10 - adverse effects ; Interleukin-10 - blood ; Interleukin-10 - pharmacokinetics ; Kidney - physiology ; Kidney Function Tests ; Medical sciences ; Metabolic Clearance Rate ; Middle Aged ; Muscular Diseases - chemically induced ; Pain - chemically induced ; Pharmacology. Drug treatments ; Recombinant Proteins - adverse effects ; Recombinant Proteins - blood ; Recombinant Proteins - pharmacokinetics</subject><ispartof>Journal of clinical pharmacology, 1999-10, Vol.39 (10), p.1015-1020</ispartof><rights>1999 American College of Clinical Pharmacology</rights><rights>1999 SAGE Publications</rights><rights>1999 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4563-b50a619b8a311df71f66721720789739b3fa25005c848ee3eb18454ab62141953</citedby><cites>FETCH-LOGICAL-c4563-b50a619b8a311df71f66721720789739b3fa25005c848ee3eb18454ab62141953</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1177%2F00912709922011773$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1177%2F00912709922011773$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1956217$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10516935$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Andersen, Scott R.</creatorcontrib><creatorcontrib>Lambrecht, Lawrence J.</creatorcontrib><creatorcontrib>Swan, Suzanne K.</creatorcontrib><creatorcontrib>Cutler, David L.</creatorcontrib><creatorcontrib>Radwanski, Elaine</creatorcontrib><creatorcontrib>Affrime, Melton B.</creatorcontrib><creatorcontrib>Garaud, Jean-Jacques</creatorcontrib><title>Disposition of Recombinant Human Interleukin-10 in Subjects with Various Degrees of Renal Function</title><title>Journal of clinical pharmacology</title><addtitle>J Clin Pharmacol</addtitle><description>The pharmacokinetics of intravenously administered recombinant human interleukin‐10 (rHuIL‐10) were evaluated in 18 subjects with creatinine clearances (Clcr) between 2.7 and 116.7 mL/min/1.73m2. Serum samples for rHuIL‐10 were obtained over a 48‐hour period after a single 25 μg/kg IV bolus infusion. AUC, total body clearance (Clp), and steady‐state volume of distribution (Vdss) were derived by compartmental methods. Analysis of serum concentrations showed statistically significant group differences for log‐transformed AUC and original scale Clp (p < 0.01). The AUC and effective half‐life increased, while the mean Clp of rHuIL‐10 decreased as renal function declined. A linear relationship between AUC and Clcr as well as Clp and Clcr demonstrates that the disposition of rHuIL‐10 is altered in subjects with renal insufficiency. No serious adverse events were noted.</description><subject>Adult</subject><subject>Aged</subject><subject>Area Under Curve</subject><subject>Biological and medical sciences</subject><subject>Creatinine - urine</subject><subject>Data Interpretation, Statistical</subject><subject>Fever - chemically induced</subject><subject>Flushing - chemically induced</subject><subject>Headache - chemically induced</subject><subject>Humans</subject><subject>Immunomodulators</subject><subject>Interleukin-10 - adverse effects</subject><subject>Interleukin-10 - blood</subject><subject>Interleukin-10 - pharmacokinetics</subject><subject>Kidney - physiology</subject><subject>Kidney Function Tests</subject><subject>Medical sciences</subject><subject>Metabolic Clearance Rate</subject><subject>Middle Aged</subject><subject>Muscular Diseases - chemically induced</subject><subject>Pain - chemically induced</subject><subject>Pharmacology. Drug treatments</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - blood</subject><subject>Recombinant Proteins - pharmacokinetics</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc1u1DAUhS0EokPhAdggL9iG3uvfeIlm2k6rqiAKZRk5qcO4k3FGdqKhb4-jjACJBRtbvj7fOdYxIW8RPiBqfQZgkGkwhjGYBvwZWaCUrBAKxHOymO6LLIAT8iqlRwBUQuJLcoIgURkuF6Re-bTvkx98H2jf0i-u6Xe1DzYMdD3ubKBXYXCxc-PWhwKB-kDvxvrRNUOiBz9s6L2Nvh8TXbkf0bk0mwTb0YsxNJPta_KitV1yb477Kfl2cf51uS5uPl1eLT_eFI2Qihe1BKvQ1KXliA-txlYpzVAz0KXR3NS8tUwCyKYUpXPc1VgKKWytGAo0kp8SnH2b2KcUXVvto9_Z-FQhVFM91T99ZebdzOzHeuce_iLmgrLg_VFgU2O7NtrQ-PRHZ2SO11kmZtmh73JdaduNBxerjbPdsMm5ACJ_Q4HGGJxOxbRM8eqI-c49_f-91fXy85oDy2Axgz4N7udv0MZtpTTXsvp-e1ndq9Wtucs-jP8C_YOeaA</recordid><startdate>199910</startdate><enddate>199910</enddate><creator>Andersen, Scott R.</creator><creator>Lambrecht, Lawrence J.</creator><creator>Swan, Suzanne K.</creator><creator>Cutler, David L.</creator><creator>Radwanski, Elaine</creator><creator>Affrime, Melton B.</creator><creator>Garaud, Jean-Jacques</creator><general>Blackwell Publishing Ltd</general><general>SAGE Publications</general><general>Sage Science</general><scope>BSCLL</scope><scope>IQODW</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></search><sort><creationdate>199910</creationdate><title>Disposition of Recombinant Human Interleukin-10 in Subjects with Various Degrees of Renal Function</title><author>Andersen, Scott R. ; Lambrecht, Lawrence J. ; Swan, Suzanne K. ; Cutler, David L. ; Radwanski, Elaine ; Affrime, Melton B. ; Garaud, Jean-Jacques</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4563-b50a619b8a311df71f66721720789739b3fa25005c848ee3eb18454ab62141953</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Area Under Curve</topic><topic>Biological and medical sciences</topic><topic>Creatinine - urine</topic><topic>Data Interpretation, Statistical</topic><topic>Fever - chemically induced</topic><topic>Flushing - chemically induced</topic><topic>Headache - chemically induced</topic><topic>Humans</topic><topic>Immunomodulators</topic><topic>Interleukin-10 - adverse effects</topic><topic>Interleukin-10 - blood</topic><topic>Interleukin-10 - pharmacokinetics</topic><topic>Kidney - physiology</topic><topic>Kidney Function Tests</topic><topic>Medical sciences</topic><topic>Metabolic Clearance Rate</topic><topic>Middle Aged</topic><topic>Muscular Diseases - chemically induced</topic><topic>Pain - chemically induced</topic><topic>Pharmacology. Drug treatments</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - blood</topic><topic>Recombinant Proteins - pharmacokinetics</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Andersen, Scott R.</creatorcontrib><creatorcontrib>Lambrecht, Lawrence J.</creatorcontrib><creatorcontrib>Swan, Suzanne K.</creatorcontrib><creatorcontrib>Cutler, David L.</creatorcontrib><creatorcontrib>Radwanski, Elaine</creatorcontrib><creatorcontrib>Affrime, Melton B.</creatorcontrib><creatorcontrib>Garaud, Jean-Jacques</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Andersen, Scott R.</au><au>Lambrecht, Lawrence J.</au><au>Swan, Suzanne K.</au><au>Cutler, David L.</au><au>Radwanski, Elaine</au><au>Affrime, Melton B.</au><au>Garaud, Jean-Jacques</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Disposition of Recombinant Human Interleukin-10 in Subjects with Various Degrees of Renal Function</atitle><jtitle>Journal of clinical pharmacology</jtitle><addtitle>J Clin Pharmacol</addtitle><date>1999-10</date><risdate>1999</risdate><volume>39</volume><issue>10</issue><spage>1015</spage><epage>1020</epage><pages>1015-1020</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><coden>JCPCBR</coden><abstract>The pharmacokinetics of intravenously administered recombinant human interleukin‐10 (rHuIL‐10) were evaluated in 18 subjects with creatinine clearances (Clcr) between 2.7 and 116.7 mL/min/1.73m2. Serum samples for rHuIL‐10 were obtained over a 48‐hour period after a single 25 μg/kg IV bolus infusion. AUC, total body clearance (Clp), and steady‐state volume of distribution (Vdss) were derived by compartmental methods. Analysis of serum concentrations showed statistically significant group differences for log‐transformed AUC and original scale Clp (p < 0.01). The AUC and effective half‐life increased, while the mean Clp of rHuIL‐10 decreased as renal function declined. A linear relationship between AUC and Clcr as well as Clp and Clcr demonstrates that the disposition of rHuIL‐10 is altered in subjects with renal insufficiency. No serious adverse events were noted.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>10516935</pmid><doi>10.1177/00912709922011773</doi><tpages>6</tpages></addata></record> |
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| ispartof | Journal of clinical pharmacology, 1999-10, Vol.39 (10), p.1015-1020 |
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| subjects | Adult Aged Area Under Curve Biological and medical sciences Creatinine - urine Data Interpretation, Statistical Fever - chemically induced Flushing - chemically induced Headache - chemically induced Humans Immunomodulators Interleukin-10 - adverse effects Interleukin-10 - blood Interleukin-10 - pharmacokinetics Kidney - physiology Kidney Function Tests Medical sciences Metabolic Clearance Rate Middle Aged Muscular Diseases - chemically induced Pain - chemically induced Pharmacology. Drug treatments Recombinant Proteins - adverse effects Recombinant Proteins - blood Recombinant Proteins - pharmacokinetics |
| title | Disposition of Recombinant Human Interleukin-10 in Subjects with Various Degrees of Renal Function |
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