Open-Label, Multicenter Study on the Safety, Tolerability, and Efficacy of Simulect in Pediatric Renal Transplant Recipients Receiving Triple Therapy With Cyclosporin, Mycophenolate, and Corticosteroids
Basiliximab is a monoclonal antibody directed to theinterleukin-2 receptor. Several studies have demonstrated both its efficacy and safety. Even with the use of polyclonal antibodies in renal pediatric transplant recipients, the local incidence of steroid-resistant rejections has been close to 10% o...
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description | Basiliximab is a monoclonal antibody directed to theinterleukin-2 receptor. Several studies have demonstrated both its efficacy and safety. Even with the use of polyclonal antibodies in renal pediatric transplant recipients, the local incidence of steroid-resistant rejections has been close to 10% of the total incidence of acute rejection episodes (AREs). An open, multicenter prospective study was performed to assess the safety tolerability, and efficacy of induction with basiliximab in renal pediatric transplant patients receiving cyclosporine, mycophenolate, and steroids.
Eighteen patients (8 boys) of mean age 11.9 ± 4.5 years and body weight 32 ± 15 kg received cadaveric (n = 7) or living (n = 11) donor grafts. Simulect was administered on days 0 and 4. Efficacy was assessed by the incidence of biopsy-proven acute rejection (BPAR). Safety assessment consisted of a description of the adverse events (AEs).
Six BPAR (Banff I and II) occurred in 5, (27.7%) children all of which were steroid responsive. Creatinine levels at day 7 and months 3, 6, and 12 were 1.6 ± 1.5 mg/dL, 1.0 ± 0.4 mg/dL, 1.0 ± 0.5 mg/dL, and 1.0 ± 0.4 mg/dL, respectively. Schwartz calculation at 12 months was 71 ± 15 mL/1.73 m
2 AEs were hypertension (12), anemia (9), abdominal pain (8), metabolic acidosis (8), nausea (7), diarrhea (2), gingival hypertrophy (2), hirsutism (2), lymphocele (2), and infections (15). No deaths, graft losses, PTLDs, or malignancies were observed.
No steroid-resistant AREs, were observed in this pediatric group using basiliximab. The Schwartz calculation at 12 months was 71 ± 15 mL/min/1.73 m
2. |
doi_str_mv | 10.1016/j.transproceed.2005.02.022 |
format | Article |
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Eighteen patients (8 boys) of mean age 11.9 ± 4.5 years and body weight 32 ± 15 kg received cadaveric (n = 7) or living (n = 11) donor grafts. Simulect was administered on days 0 and 4. Efficacy was assessed by the incidence of biopsy-proven acute rejection (BPAR). Safety assessment consisted of a description of the adverse events (AEs).
Six BPAR (Banff I and II) occurred in 5, (27.7%) children all of which were steroid responsive. Creatinine levels at day 7 and months 3, 6, and 12 were 1.6 ± 1.5 mg/dL, 1.0 ± 0.4 mg/dL, 1.0 ± 0.5 mg/dL, and 1.0 ± 0.4 mg/dL, respectively. Schwartz calculation at 12 months was 71 ± 15 mL/1.73 m
2 AEs were hypertension (12), anemia (9), abdominal pain (8), metabolic acidosis (8), nausea (7), diarrhea (2), gingival hypertrophy (2), hirsutism (2), lymphocele (2), and infections (15). No deaths, graft losses, PTLDs, or malignancies were observed.
No steroid-resistant AREs, were observed in this pediatric group using basiliximab. The Schwartz calculation at 12 months was 71 ± 15 mL/min/1.73 m
2.</description><identifier>ISSN: 0041-1345</identifier><identifier>EISSN: 1873-2623</identifier><identifier>DOI: 10.1016/j.transproceed.2005.02.022</identifier><identifier>PMID: 15848497</identifier><identifier>CODEN: TRPPA8</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adrenal Cortex Hormones - therapeutic use ; Antibodies, Monoclonal - therapeutic use ; Biological and medical sciences ; Biopsy ; Cadaver ; Child ; Cyclosporine - therapeutic use ; Drug Therapy, Combination ; Female ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; Graft Rejection - pathology ; Histocompatibility Testing ; Humans ; Immunosuppressive Agents - therapeutic use ; Kidney Transplantation - immunology ; Living Donors ; Male ; Medical sciences ; Mycophenolic Acid - therapeutic use ; Prospective Studies ; Recombinant Fusion Proteins - therapeutic use ; Safety ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Tissue Donors ; Tissue, organ and graft immunology</subject><ispartof>Transplantation proceedings, 2005-03, Vol.37 (2), p.672-674</ispartof><rights>2005 Elsevier Inc.</rights><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c408t-e208d025d19de204978454d9bfef8b59c0e782867720da00c3c7ab67c37c12503</citedby><cites>FETCH-LOGICAL-c408t-e208d025d19de204978454d9bfef8b59c0e782867720da00c3c7ab67c37c12503</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.transproceed.2005.02.022$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>309,310,314,780,784,789,790,3550,23930,23931,25140,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16846973$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15848497$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Turconi, A.</creatorcontrib><creatorcontrib>Rodriguez Rilo, L.</creatorcontrib><creatorcontrib>Goldberg, J.</creatorcontrib><creatorcontrib>de Boccardo, G.</creatorcontrib><creatorcontrib>Garsd, A.</creatorcontrib><creatorcontrib>Otero, A.</creatorcontrib><title>Open-Label, Multicenter Study on the Safety, Tolerability, and Efficacy of Simulect in Pediatric Renal Transplant Recipients Receiving Triple Therapy With Cyclosporin, Mycophenolate, and Corticosteroids</title><title>Transplantation proceedings</title><addtitle>Transplant Proc</addtitle><description>Basiliximab is a monoclonal antibody directed to theinterleukin-2 receptor. Several studies have demonstrated both its efficacy and safety. Even with the use of polyclonal antibodies in renal pediatric transplant recipients, the local incidence of steroid-resistant rejections has been close to 10% of the total incidence of acute rejection episodes (AREs). An open, multicenter prospective study was performed to assess the safety tolerability, and efficacy of induction with basiliximab in renal pediatric transplant patients receiving cyclosporine, mycophenolate, and steroids.
Eighteen patients (8 boys) of mean age 11.9 ± 4.5 years and body weight 32 ± 15 kg received cadaveric (n = 7) or living (n = 11) donor grafts. Simulect was administered on days 0 and 4. Efficacy was assessed by the incidence of biopsy-proven acute rejection (BPAR). Safety assessment consisted of a description of the adverse events (AEs).
Six BPAR (Banff I and II) occurred in 5, (27.7%) children all of which were steroid responsive. Creatinine levels at day 7 and months 3, 6, and 12 were 1.6 ± 1.5 mg/dL, 1.0 ± 0.4 mg/dL, 1.0 ± 0.5 mg/dL, and 1.0 ± 0.4 mg/dL, respectively. Schwartz calculation at 12 months was 71 ± 15 mL/1.73 m
2 AEs were hypertension (12), anemia (9), abdominal pain (8), metabolic acidosis (8), nausea (7), diarrhea (2), gingival hypertrophy (2), hirsutism (2), lymphocele (2), and infections (15). No deaths, graft losses, PTLDs, or malignancies were observed.
No steroid-resistant AREs, were observed in this pediatric group using basiliximab. The Schwartz calculation at 12 months was 71 ± 15 mL/min/1.73 m
2.</description><subject>Adrenal Cortex Hormones - therapeutic use</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Biopsy</subject><subject>Cadaver</subject><subject>Child</subject><subject>Cyclosporine - therapeutic use</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Fundamental immunology</subject><subject>Graft Rejection - pathology</subject><subject>Histocompatibility Testing</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Kidney Transplantation - immunology</subject><subject>Living Donors</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Mycophenolic Acid - therapeutic use</subject><subject>Prospective Studies</subject><subject>Recombinant Fusion Proteins - therapeutic use</subject><subject>Safety</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Tissue Donors</subject><subject>Tissue, organ and graft immunology</subject><issn>0041-1345</issn><issn>1873-2623</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkd-KEzEUxgdR3Lr6ChIEvdqpmcy_1Dupu6tQWbEVL0MmOWNT0mQ2ySzMK_pUnrFFvRQCyUl-55wv58uyVwVdFrRo3h6WKUgXh-AVgF4ySuslZbjYo2xR8LbMWcPKx9mC0qrIi7KqL7JnMR4oxqwqn2YXRc0rXq3aRfbzbgCXb2QH9op8Hm0yClyCQLZp1BPxjqQ9kK3sIU1XZOctBNkZa-ZIOk2u-94oqZDsydYcRwsqEePIF9BGpmAU-QpOWrL7rdhKl_BCmcFglzgfwTwY9wPfzWCB7PZYf5jId5P2ZD0p6-Pgg3GobVJ-2IPzViY49V77gHJ9RLne6Pg8e9JLG-HFeb_Mvt1c79Yf883d7af1-02uKspTDoxyTVmti5XGM06BV3WlV10PPe_qlaLQcsabtmVUS0pVqVrZNa0qW1WwmpaX2ZtTXTTgfoSYxNFEBRY_B36MAjPbtuQMwXcnUAUfY4BeDMEcZZhEQcXspDiIf50Us5OCMlxz8stzl7E74tuf1LN1CLw-AzIqaXsspEz8yzW8ahBD7sOJA5zJg4EgosLpKzQooFlCe_M_en4B-tPHlQ</recordid><startdate>20050301</startdate><enddate>20050301</enddate><creator>Turconi, A.</creator><creator>Rodriguez Rilo, L.</creator><creator>Goldberg, J.</creator><creator>de Boccardo, G.</creator><creator>Garsd, A.</creator><creator>Otero, A.</creator><general>Elsevier Inc</general><general>Elsevier Science</general><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><scope>7X8</scope></search><sort><creationdate>20050301</creationdate><title>Open-Label, Multicenter Study on the Safety, Tolerability, and Efficacy of Simulect in Pediatric Renal Transplant Recipients Receiving Triple Therapy With Cyclosporin, Mycophenolate, and Corticosteroids</title><author>Turconi, A. ; Rodriguez Rilo, L. ; Goldberg, J. ; de Boccardo, G. ; Garsd, A. ; Otero, A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c408t-e208d025d19de204978454d9bfef8b59c0e782867720da00c3c7ab67c37c12503</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adrenal Cortex Hormones - therapeutic use</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Biopsy</topic><topic>Cadaver</topic><topic>Child</topic><topic>Cyclosporine - therapeutic use</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Fundamental immunology</topic><topic>Graft Rejection - pathology</topic><topic>Histocompatibility Testing</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Kidney Transplantation - immunology</topic><topic>Living Donors</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mycophenolic Acid - therapeutic use</topic><topic>Prospective Studies</topic><topic>Recombinant Fusion Proteins - therapeutic use</topic><topic>Safety</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Tissue Donors</topic><topic>Tissue, organ and graft immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Turconi, A.</creatorcontrib><creatorcontrib>Rodriguez Rilo, L.</creatorcontrib><creatorcontrib>Goldberg, J.</creatorcontrib><creatorcontrib>de Boccardo, G.</creatorcontrib><creatorcontrib>Garsd, A.</creatorcontrib><creatorcontrib>Otero, A.</creatorcontrib><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><collection>MEDLINE - Academic</collection><jtitle>Transplantation proceedings</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Turconi, A.</au><au>Rodriguez Rilo, L.</au><au>Goldberg, J.</au><au>de Boccardo, G.</au><au>Garsd, A.</au><au>Otero, A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Open-Label, Multicenter Study on the Safety, Tolerability, and Efficacy of Simulect in Pediatric Renal Transplant Recipients Receiving Triple Therapy With Cyclosporin, Mycophenolate, and Corticosteroids</atitle><jtitle>Transplantation proceedings</jtitle><addtitle>Transplant Proc</addtitle><date>2005-03-01</date><risdate>2005</risdate><volume>37</volume><issue>2</issue><spage>672</spage><epage>674</epage><pages>672-674</pages><issn>0041-1345</issn><eissn>1873-2623</eissn><coden>TRPPA8</coden><abstract>Basiliximab is a monoclonal antibody directed to theinterleukin-2 receptor. Several studies have demonstrated both its efficacy and safety. Even with the use of polyclonal antibodies in renal pediatric transplant recipients, the local incidence of steroid-resistant rejections has been close to 10% of the total incidence of acute rejection episodes (AREs). An open, multicenter prospective study was performed to assess the safety tolerability, and efficacy of induction with basiliximab in renal pediatric transplant patients receiving cyclosporine, mycophenolate, and steroids.
Eighteen patients (8 boys) of mean age 11.9 ± 4.5 years and body weight 32 ± 15 kg received cadaveric (n = 7) or living (n = 11) donor grafts. Simulect was administered on days 0 and 4. Efficacy was assessed by the incidence of biopsy-proven acute rejection (BPAR). Safety assessment consisted of a description of the adverse events (AEs).
Six BPAR (Banff I and II) occurred in 5, (27.7%) children all of which were steroid responsive. Creatinine levels at day 7 and months 3, 6, and 12 were 1.6 ± 1.5 mg/dL, 1.0 ± 0.4 mg/dL, 1.0 ± 0.5 mg/dL, and 1.0 ± 0.4 mg/dL, respectively. Schwartz calculation at 12 months was 71 ± 15 mL/1.73 m
2 AEs were hypertension (12), anemia (9), abdominal pain (8), metabolic acidosis (8), nausea (7), diarrhea (2), gingival hypertrophy (2), hirsutism (2), lymphocele (2), and infections (15). No deaths, graft losses, PTLDs, or malignancies were observed.
No steroid-resistant AREs, were observed in this pediatric group using basiliximab. The Schwartz calculation at 12 months was 71 ± 15 mL/min/1.73 m
2.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>15848497</pmid><doi>10.1016/j.transproceed.2005.02.022</doi><tpages>3</tpages></addata></record> |
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subjects | Adrenal Cortex Hormones - therapeutic use Antibodies, Monoclonal - therapeutic use Biological and medical sciences Biopsy Cadaver Child Cyclosporine - therapeutic use Drug Therapy, Combination Female Fundamental and applied biological sciences. Psychology Fundamental immunology Graft Rejection - pathology Histocompatibility Testing Humans Immunosuppressive Agents - therapeutic use Kidney Transplantation - immunology Living Donors Male Medical sciences Mycophenolic Acid - therapeutic use Prospective Studies Recombinant Fusion Proteins - therapeutic use Safety Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Tissue Donors Tissue, organ and graft immunology |
title | Open-Label, Multicenter Study on the Safety, Tolerability, and Efficacy of Simulect in Pediatric Renal Transplant Recipients Receiving Triple Therapy With Cyclosporin, Mycophenolate, and Corticosteroids |
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