Efficacy and safety of the new antiviral agents for the treatment of hepatitis C virus infection in Egyptian renal transplant recipients
Purpose Hepatitis C virus (HCV) infection in kidney transplant recipients (KTRs) is common and can impact on patient and graft survival rates. The efficacy and safety of direct-acting antivirals (DAAs) to treat genotype-4 HCV-infected KTRs have not been fully established. Methods A prospective, sing...
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| Veröffentlicht in: | International urology and nephrology 2019-12, Vol.51 (12), p.2295-2304 |
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| container_title | International urology and nephrology |
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| creator | Maghrabi, Hanzada Mohamed El Elmowafy, Ahmed Yahia Refaie, Ayman Fathi Elbasiony, Mohammed Adel Shiha, Gamal Elsayed Rostaing, Lionel Bakr, Mohamed Adel |
| description | Purpose
Hepatitis C virus (HCV) infection in kidney transplant recipients (KTRs) is common and can impact on patient and graft survival rates. The efficacy and safety of direct-acting antivirals (DAAs) to treat genotype-4 HCV-infected KTRs have not been fully established.
Methods
A prospective, single-arm, single-center study was conducted at Mansoura Urology/Nephrology Center (Mansoura University, Egypt). 114 HCV RNA(+) genotype 4 KTRs were enrolled in this study after a hepatology consultation and consented to start treatment with interferon-free DAAs. A sofosbuvir-based regimen was given to 109 recipients that had creatinine clearance (Crcl) of > 30 mL/min/1.73 m
2
. Ritonavir-boosted paritaprevir/ombitasvir was prescribed to five recipients with Crcl |
| doi_str_mv | 10.1007/s11255-019-02272-5 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2291821113</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2291821113</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-421cd91cd63eab07517e59228af6ce2ae336ec1166765536c4a221aedcc164ab3</originalsourceid><addsrcrecordid>eNp9kMFuGyEQhlHVKHGTvEAPFVLOmzBg2N1jZTltpEi9tGc0xoONZbNbwIn8Bn3s4DhNbz0g0Mw336Cfsc8gbkGI9i4DSK0bAX0jpGxloz-wCehWNVJ3049sIpSABoxUF-xTzhshRN8Jcc4uFGgFnWgn7M_c--DQHTjGJc_oqRz44HlZE4_0XKslPIWEW44riiVzP6TXZkmEZVdLR3pNI5ZQQuYzXul95iF6ciUMsb74fHUYS8DIE8VqKgljHrdVXQsujOEovmJnHreZrt_uS_brfv5z9r15_PHtYfb1sXGq1aWZSnDLvh6jCBei1dCS7qXs0BtHEkkpQw7AmNZorYybopSAtHQOzBQX6pLdnLxjGn7vKRe7GfapfitbKXvoJACoSskT5dKQcyJvxxR2mA4WhD2Gb0_h2xq-fQ3f6jr05U29X-xo-T7yN-0KqBOQayuuKP3b_R_tCzV0kXo</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2291821113</pqid></control><display><type>article</type><title>Efficacy and safety of the new antiviral agents for the treatment of hepatitis C virus infection in Egyptian renal transplant recipients</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Maghrabi, Hanzada Mohamed El ; Elmowafy, Ahmed Yahia ; Refaie, Ayman Fathi ; Elbasiony, Mohammed Adel ; Shiha, Gamal Elsayed ; Rostaing, Lionel ; Bakr, Mohamed Adel</creator><creatorcontrib>Maghrabi, Hanzada Mohamed El ; Elmowafy, Ahmed Yahia ; Refaie, Ayman Fathi ; Elbasiony, Mohammed Adel ; Shiha, Gamal Elsayed ; Rostaing, Lionel ; Bakr, Mohamed Adel</creatorcontrib><description>Purpose
Hepatitis C virus (HCV) infection in kidney transplant recipients (KTRs) is common and can impact on patient and graft survival rates. The efficacy and safety of direct-acting antivirals (DAAs) to treat genotype-4 HCV-infected KTRs have not been fully established.
Methods
A prospective, single-arm, single-center study was conducted at Mansoura Urology/Nephrology Center (Mansoura University, Egypt). 114 HCV RNA(+) genotype 4 KTRs were enrolled in this study after a hepatology consultation and consented to start treatment with interferon-free DAAs. A sofosbuvir-based regimen was given to 109 recipients that had creatinine clearance (Crcl) of > 30 mL/min/1.73 m
2
. Ritonavir-boosted paritaprevir/ombitasvir was prescribed to five recipients with Crcl < 30 mL/min/1.73 m
2
.
Results
The mean age of the cohort was 45.2 ± 11.2 years; most were male. The mean duration with a transplant was 14.2 ± 3.5 years, with different immunosuppressive regimens, mostly based on calcineurin inhibitors. A rapid virological response (RVR), i.e., clearance of viral load, was achieved in 100% at 4 weeks after starting treatment. All patients had a sustained virological response (SVR) at 12 and 24 weeks posttreatment, with one exception. During DAA therapy serum creatinine increased in 12 patients. In three, this was concomitant with elevated calcineurin inhibitor and sirolimus trough levels. Graft biopsies were performed in 8 of these 12 patients: these revealed an acute rejection in 4 cases (acute cellular rejection grade-1A:
n
= 2, and grade-1B:
n
= 2). The rejection episodes occurred at 4–6 weeks after starting treatment.
Conclusion
DAAs were highly efficacious and safely treated genotype-4 HCV-infected KTRs and had no significant adverse effects on graft function/survival.</description><identifier>ISSN: 0301-1623</identifier><identifier>EISSN: 1573-2584</identifier><identifier>DOI: 10.1007/s11255-019-02272-5</identifier><identifier>PMID: 31531807</identifier><language>eng</language><publisher>Dordrecht: Springer Netherlands</publisher><subject>Adult ; Antiviral agents ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Antiviral drugs ; Calcineurin ; Calcineurin inhibitors ; Creatinine ; Egypt ; Female ; Genotype ; Genotype & phenotype ; Genotypes ; Graft rejection ; Health risk assessment ; Hepacivirus - genetics ; Hepatitis ; Hepatitis C ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Humans ; Immunosuppressive agents ; Interferon ; Kidney Transplantation ; Kidney transplants ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Nephrology ; Nephrology - Original Paper ; Postoperative Complications - drug therapy ; Postoperative Complications - virology ; Prospective Studies ; Rapamycin ; Ribonucleic acid ; Ritonavir ; RNA ; Treatment Outcome ; Urology</subject><ispartof>International urology and nephrology, 2019-12, Vol.51 (12), p.2295-2304</ispartof><rights>Springer Nature B.V. 2019</rights><rights>International Urology and Nephrology is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-421cd91cd63eab07517e59228af6ce2ae336ec1166765536c4a221aedcc164ab3</citedby><cites>FETCH-LOGICAL-c375t-421cd91cd63eab07517e59228af6ce2ae336ec1166765536c4a221aedcc164ab3</cites><orcidid>0000-0002-5130-7286</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11255-019-02272-5$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11255-019-02272-5$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31531807$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maghrabi, Hanzada Mohamed El</creatorcontrib><creatorcontrib>Elmowafy, Ahmed Yahia</creatorcontrib><creatorcontrib>Refaie, Ayman Fathi</creatorcontrib><creatorcontrib>Elbasiony, Mohammed Adel</creatorcontrib><creatorcontrib>Shiha, Gamal Elsayed</creatorcontrib><creatorcontrib>Rostaing, Lionel</creatorcontrib><creatorcontrib>Bakr, Mohamed Adel</creatorcontrib><title>Efficacy and safety of the new antiviral agents for the treatment of hepatitis C virus infection in Egyptian renal transplant recipients</title><title>International urology and nephrology</title><addtitle>Int Urol Nephrol</addtitle><addtitle>Int Urol Nephrol</addtitle><description>Purpose
Hepatitis C virus (HCV) infection in kidney transplant recipients (KTRs) is common and can impact on patient and graft survival rates. The efficacy and safety of direct-acting antivirals (DAAs) to treat genotype-4 HCV-infected KTRs have not been fully established.
Methods
A prospective, single-arm, single-center study was conducted at Mansoura Urology/Nephrology Center (Mansoura University, Egypt). 114 HCV RNA(+) genotype 4 KTRs were enrolled in this study after a hepatology consultation and consented to start treatment with interferon-free DAAs. A sofosbuvir-based regimen was given to 109 recipients that had creatinine clearance (Crcl) of > 30 mL/min/1.73 m
2
. Ritonavir-boosted paritaprevir/ombitasvir was prescribed to five recipients with Crcl < 30 mL/min/1.73 m
2
.
Results
The mean age of the cohort was 45.2 ± 11.2 years; most were male. The mean duration with a transplant was 14.2 ± 3.5 years, with different immunosuppressive regimens, mostly based on calcineurin inhibitors. A rapid virological response (RVR), i.e., clearance of viral load, was achieved in 100% at 4 weeks after starting treatment. All patients had a sustained virological response (SVR) at 12 and 24 weeks posttreatment, with one exception. During DAA therapy serum creatinine increased in 12 patients. In three, this was concomitant with elevated calcineurin inhibitor and sirolimus trough levels. Graft biopsies were performed in 8 of these 12 patients: these revealed an acute rejection in 4 cases (acute cellular rejection grade-1A:
n
= 2, and grade-1B:
n
= 2). The rejection episodes occurred at 4–6 weeks after starting treatment.
Conclusion
DAAs were highly efficacious and safely treated genotype-4 HCV-infected KTRs and had no significant adverse effects on graft function/survival.</description><subject>Adult</subject><subject>Antiviral agents</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Antiviral drugs</subject><subject>Calcineurin</subject><subject>Calcineurin inhibitors</subject><subject>Creatinine</subject><subject>Egypt</subject><subject>Female</subject><subject>Genotype</subject><subject>Genotype & phenotype</subject><subject>Genotypes</subject><subject>Graft rejection</subject><subject>Health risk assessment</subject><subject>Hepacivirus - genetics</subject><subject>Hepatitis</subject><subject>Hepatitis C</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Humans</subject><subject>Immunosuppressive agents</subject><subject>Interferon</subject><subject>Kidney Transplantation</subject><subject>Kidney transplants</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Nephrology</subject><subject>Nephrology - Original Paper</subject><subject>Postoperative Complications - drug therapy</subject><subject>Postoperative Complications - virology</subject><subject>Prospective Studies</subject><subject>Rapamycin</subject><subject>Ribonucleic acid</subject><subject>Ritonavir</subject><subject>RNA</subject><subject>Treatment Outcome</subject><subject>Urology</subject><issn>0301-1623</issn><issn>1573-2584</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kMFuGyEQhlHVKHGTvEAPFVLOmzBg2N1jZTltpEi9tGc0xoONZbNbwIn8Bn3s4DhNbz0g0Mw336Cfsc8gbkGI9i4DSK0bAX0jpGxloz-wCehWNVJ3049sIpSABoxUF-xTzhshRN8Jcc4uFGgFnWgn7M_c--DQHTjGJc_oqRz44HlZE4_0XKslPIWEW44riiVzP6TXZkmEZVdLR3pNI5ZQQuYzXul95iF6ciUMsb74fHUYS8DIE8VqKgljHrdVXQsujOEovmJnHreZrt_uS_brfv5z9r15_PHtYfb1sXGq1aWZSnDLvh6jCBei1dCS7qXs0BtHEkkpQw7AmNZorYybopSAtHQOzBQX6pLdnLxjGn7vKRe7GfapfitbKXvoJACoSskT5dKQcyJvxxR2mA4WhD2Gb0_h2xq-fQ3f6jr05U29X-xo-T7yN-0KqBOQayuuKP3b_R_tCzV0kXo</recordid><startdate>20191201</startdate><enddate>20191201</enddate><creator>Maghrabi, Hanzada Mohamed El</creator><creator>Elmowafy, Ahmed Yahia</creator><creator>Refaie, Ayman Fathi</creator><creator>Elbasiony, Mohammed Adel</creator><creator>Shiha, Gamal Elsayed</creator><creator>Rostaing, Lionel</creator><creator>Bakr, Mohamed Adel</creator><general>Springer Netherlands</general><general>Springer Nature B.V</general><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>3V.</scope><scope>7QP</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><orcidid>https://orcid.org/0000-0002-5130-7286</orcidid></search><sort><creationdate>20191201</creationdate><title>Efficacy and safety of the new antiviral agents for the treatment of hepatitis C virus infection in Egyptian renal transplant recipients</title><author>Maghrabi, Hanzada Mohamed El ; Elmowafy, Ahmed Yahia ; Refaie, Ayman Fathi ; Elbasiony, Mohammed Adel ; Shiha, Gamal Elsayed ; Rostaing, Lionel ; Bakr, Mohamed Adel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-421cd91cd63eab07517e59228af6ce2ae336ec1166765536c4a221aedcc164ab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Antiviral agents</topic><topic>Antiviral Agents - adverse effects</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Antiviral drugs</topic><topic>Calcineurin</topic><topic>Calcineurin inhibitors</topic><topic>Creatinine</topic><topic>Egypt</topic><topic>Female</topic><topic>Genotype</topic><topic>Genotype & phenotype</topic><topic>Genotypes</topic><topic>Graft rejection</topic><topic>Health risk assessment</topic><topic>Hepacivirus - genetics</topic><topic>Hepatitis</topic><topic>Hepatitis C</topic><topic>Hepatitis C, Chronic - drug therapy</topic><topic>Hepatitis C, Chronic - virology</topic><topic>Humans</topic><topic>Immunosuppressive agents</topic><topic>Interferon</topic><topic>Kidney Transplantation</topic><topic>Kidney transplants</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Nephrology</topic><topic>Nephrology - Original Paper</topic><topic>Postoperative Complications - drug therapy</topic><topic>Postoperative Complications - virology</topic><topic>Prospective Studies</topic><topic>Rapamycin</topic><topic>Ribonucleic acid</topic><topic>Ritonavir</topic><topic>RNA</topic><topic>Treatment Outcome</topic><topic>Urology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maghrabi, Hanzada Mohamed El</creatorcontrib><creatorcontrib>Elmowafy, Ahmed Yahia</creatorcontrib><creatorcontrib>Refaie, Ayman Fathi</creatorcontrib><creatorcontrib>Elbasiony, Mohammed Adel</creatorcontrib><creatorcontrib>Shiha, Gamal Elsayed</creatorcontrib><creatorcontrib>Rostaing, Lionel</creatorcontrib><creatorcontrib>Bakr, Mohamed Adel</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>International urology and nephrology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maghrabi, Hanzada Mohamed El</au><au>Elmowafy, Ahmed Yahia</au><au>Refaie, Ayman Fathi</au><au>Elbasiony, Mohammed Adel</au><au>Shiha, Gamal Elsayed</au><au>Rostaing, Lionel</au><au>Bakr, Mohamed Adel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of the new antiviral agents for the treatment of hepatitis C virus infection in Egyptian renal transplant recipients</atitle><jtitle>International urology and nephrology</jtitle><stitle>Int Urol Nephrol</stitle><addtitle>Int Urol Nephrol</addtitle><date>2019-12-01</date><risdate>2019</risdate><volume>51</volume><issue>12</issue><spage>2295</spage><epage>2304</epage><pages>2295-2304</pages><issn>0301-1623</issn><eissn>1573-2584</eissn><abstract>Purpose
Hepatitis C virus (HCV) infection in kidney transplant recipients (KTRs) is common and can impact on patient and graft survival rates. The efficacy and safety of direct-acting antivirals (DAAs) to treat genotype-4 HCV-infected KTRs have not been fully established.
Methods
A prospective, single-arm, single-center study was conducted at Mansoura Urology/Nephrology Center (Mansoura University, Egypt). 114 HCV RNA(+) genotype 4 KTRs were enrolled in this study after a hepatology consultation and consented to start treatment with interferon-free DAAs. A sofosbuvir-based regimen was given to 109 recipients that had creatinine clearance (Crcl) of > 30 mL/min/1.73 m
2
. Ritonavir-boosted paritaprevir/ombitasvir was prescribed to five recipients with Crcl < 30 mL/min/1.73 m
2
.
Results
The mean age of the cohort was 45.2 ± 11.2 years; most were male. The mean duration with a transplant was 14.2 ± 3.5 years, with different immunosuppressive regimens, mostly based on calcineurin inhibitors. A rapid virological response (RVR), i.e., clearance of viral load, was achieved in 100% at 4 weeks after starting treatment. All patients had a sustained virological response (SVR) at 12 and 24 weeks posttreatment, with one exception. During DAA therapy serum creatinine increased in 12 patients. In three, this was concomitant with elevated calcineurin inhibitor and sirolimus trough levels. Graft biopsies were performed in 8 of these 12 patients: these revealed an acute rejection in 4 cases (acute cellular rejection grade-1A:
n
= 2, and grade-1B:
n
= 2). The rejection episodes occurred at 4–6 weeks after starting treatment.
Conclusion
DAAs were highly efficacious and safely treated genotype-4 HCV-infected KTRs and had no significant adverse effects on graft function/survival.</abstract><cop>Dordrecht</cop><pub>Springer Netherlands</pub><pmid>31531807</pmid><doi>10.1007/s11255-019-02272-5</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-5130-7286</orcidid></addata></record> |
| fulltext | fulltext |
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| ispartof | International urology and nephrology, 2019-12, Vol.51 (12), p.2295-2304 |
| issn | 0301-1623 1573-2584 |
| language | eng |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Adult Antiviral agents Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Antiviral drugs Calcineurin Calcineurin inhibitors Creatinine Egypt Female Genotype Genotype & phenotype Genotypes Graft rejection Health risk assessment Hepacivirus - genetics Hepatitis Hepatitis C Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - virology Humans Immunosuppressive agents Interferon Kidney Transplantation Kidney transplants Male Medicine Medicine & Public Health Middle Aged Nephrology Nephrology - Original Paper Postoperative Complications - drug therapy Postoperative Complications - virology Prospective Studies Rapamycin Ribonucleic acid Ritonavir RNA Treatment Outcome Urology |
| title | Efficacy and safety of the new antiviral agents for the treatment of hepatitis C virus infection in Egyptian renal transplant recipients |
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