Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation
This study was undertaken to compare the efficacy and safety of tacrolimus (Tac) with the microemulsion formulation of cyclosporin (CyA) in children undergoing renal transplantation. A 6-month, randomized, prospective, open, parallel group study with an open extension phase was conducted in 18 cente...
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| Veröffentlicht in: | Pediatric nephrology (Berlin, West) West), 2002-03, Vol.17 (3), p.141-149 |
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| creator | TROMPETER, Richard FILLER, Guido KLARE, Bernd ZACCHELLO, Graziella BREKKE, Inge Bjorn MCGRAW, Mary PERNER, Ferenc GHIO, Lucian BALZAR, Egon FRIMAN, Styrbjörn GUSMANO, Rosanna STOLPE, Jochen WEBB, Nicholas J. A WATSON, Alan R MILFORD, David V TYDEN, Gunnar GRENDA, Ryszard JANDA, Jan HUGHES, David EHRICH, Jochen H. H |
| description | This study was undertaken to compare the efficacy and safety of tacrolimus (Tac) with the microemulsion formulation of cyclosporin (CyA) in children undergoing renal transplantation. A 6-month, randomized, prospective, open, parallel group study with an open extension phase was conducted in 18 centers from nine European countries. In total, 196 pediatric patients ( |
| doi_str_mv | 10.1007/s00467-001-0795-9 |
| format | Article |
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A ; WATSON, Alan R ; MILFORD, David V ; TYDEN, Gunnar ; GRENDA, Ryszard ; JANDA, Jan ; HUGHES, David ; EHRICH, Jochen H. H</creator><creatorcontrib>TROMPETER, Richard ; FILLER, Guido ; KLARE, Bernd ; ZACCHELLO, Graziella ; BREKKE, Inge Bjorn ; MCGRAW, Mary ; PERNER, Ferenc ; GHIO, Lucian ; BALZAR, Egon ; FRIMAN, Styrbjörn ; GUSMANO, Rosanna ; STOLPE, Jochen ; WEBB, Nicholas J. A ; WATSON, Alan R ; MILFORD, David V ; TYDEN, Gunnar ; GRENDA, Ryszard ; JANDA, Jan ; HUGHES, David ; EHRICH, Jochen H. H</creatorcontrib><description>This study was undertaken to compare the efficacy and safety of tacrolimus (Tac) with the microemulsion formulation of cyclosporin (CyA) in children undergoing renal transplantation. A 6-month, randomized, prospective, open, parallel group study with an open extension phase was conducted in 18 centers from nine European countries. In total, 196 pediatric patients (<18 years) were randomly assigned (1:1) to receive either Tac ( n=103) or CyA microemulsion ( n=93) administered concomitantly with azathioprine and corticosteroids. The primary endpoint was incidence and time to first acute rejection. Baseline characteristics were comparable between treatment groups. Tac therapy resulted in a significantly lower incidence of acute rejection (36.9%) compared with CyA therapy (59.1%) ( P=0.003). The incidence of corticosteroid-resistant rejection was also significantly lower in the Tac group compared with the CyA group (7.8% vs. 25.8%, P=0.001). The differences were also significant for biopsy-confirmed acute rejection (16.5% vs. 39.8%, P<0.001). At 1 year, patient survival was similar (96.1% vs. 96.6%), while 10 grafts were lost in the Tac group compared with 17 graft losses in the CyA group ( P=0.06). At 1 year, mean glomerular filtration rate (Schwartz estimate) was significantly higher in the Tac group (62+/-20 ml/min per 1.73 m(2), n=84) than in the CyA group (56+/-21 ml/min per 1.73 m(2), n=74, P=0.03). The most frequent adverse events during the first 6 months were hypertension (68.9% vs. 61.3%), hypomagnesemia (34.0% vs. 12.9%, P=0.001), and urinary tract infection (29.1% vs. 33.3%). Statistically significant differences ( P<0.05) were observed for diarrhea (13.6% vs. 3.2%), hypertrichosis (0.0% vs. 7.5%), flu syndrome (0.0% vs. 5.4%), and gum hyperplasia (0.0% vs. 5.4%). In previously non-diabetic children, the incidence of long-term (>30 days) insulin use was 3.0% (Tac) and 2.2% (CyA). Post-transplant lymphoproliferative disease was observed in 1 patient in the Tac group and 2 patients in the CyA group. In conclusion, Tac was significantly more effective than CyA microemulsion in preventing acute rejection after renal transplantation in a pediatric population. The overall safety profiles of the two regimens were comparable.</description><identifier>ISSN: 0931-041X</identifier><identifier>EISSN: 1432-198X</identifier><identifier>DOI: 10.1007/s00467-001-0795-9</identifier><identifier>PMID: 11956848</identifier><identifier>CODEN: PENED3</identifier><language>eng</language><publisher>Heidelberg: Springer</publisher><subject>Acute Disease ; Adolescent ; Biological and medical sciences ; Child ; Cyclosporine - therapeutic use ; Female ; Follow-Up Studies ; Graft Rejection ; Graft Survival ; Humans ; Immunomodulators ; Immunosuppressive Agents - therapeutic use ; Kidney Transplantation ; Male ; Medical sciences ; Pharmacology. Drug treatments ; Prospective Studies ; Tacrolimus - therapeutic use</subject><ispartof>Pediatric nephrology (Berlin, West), 2002-03, Vol.17 (3), p.141-149</ispartof><rights>2002 INIST-CNRS</rights><rights>IPNA - International Pediatric Nephrology Association New York, USA 2002</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c286t-9a6b0768ed77bd6f54b9b80a0d46c2885d5617280c9c16bb1ce1b6ece81fe27f3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13537493$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11956848$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>TROMPETER, Richard</creatorcontrib><creatorcontrib>FILLER, Guido</creatorcontrib><creatorcontrib>KLARE, Bernd</creatorcontrib><creatorcontrib>ZACCHELLO, Graziella</creatorcontrib><creatorcontrib>BREKKE, Inge Bjorn</creatorcontrib><creatorcontrib>MCGRAW, Mary</creatorcontrib><creatorcontrib>PERNER, Ferenc</creatorcontrib><creatorcontrib>GHIO, Lucian</creatorcontrib><creatorcontrib>BALZAR, Egon</creatorcontrib><creatorcontrib>FRIMAN, Styrbjörn</creatorcontrib><creatorcontrib>GUSMANO, Rosanna</creatorcontrib><creatorcontrib>STOLPE, Jochen</creatorcontrib><creatorcontrib>WEBB, Nicholas J. A</creatorcontrib><creatorcontrib>WATSON, Alan R</creatorcontrib><creatorcontrib>MILFORD, David V</creatorcontrib><creatorcontrib>TYDEN, Gunnar</creatorcontrib><creatorcontrib>GRENDA, Ryszard</creatorcontrib><creatorcontrib>JANDA, Jan</creatorcontrib><creatorcontrib>HUGHES, David</creatorcontrib><creatorcontrib>EHRICH, Jochen H. H</creatorcontrib><title>Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation</title><title>Pediatric nephrology (Berlin, West)</title><addtitle>Pediatr Nephrol</addtitle><description>This study was undertaken to compare the efficacy and safety of tacrolimus (Tac) with the microemulsion formulation of cyclosporin (CyA) in children undergoing renal transplantation. A 6-month, randomized, prospective, open, parallel group study with an open extension phase was conducted in 18 centers from nine European countries. In total, 196 pediatric patients (<18 years) were randomly assigned (1:1) to receive either Tac ( n=103) or CyA microemulsion ( n=93) administered concomitantly with azathioprine and corticosteroids. The primary endpoint was incidence and time to first acute rejection. Baseline characteristics were comparable between treatment groups. Tac therapy resulted in a significantly lower incidence of acute rejection (36.9%) compared with CyA therapy (59.1%) ( P=0.003). The incidence of corticosteroid-resistant rejection was also significantly lower in the Tac group compared with the CyA group (7.8% vs. 25.8%, P=0.001). The differences were also significant for biopsy-confirmed acute rejection (16.5% vs. 39.8%, P<0.001). At 1 year, patient survival was similar (96.1% vs. 96.6%), while 10 grafts were lost in the Tac group compared with 17 graft losses in the CyA group ( P=0.06). At 1 year, mean glomerular filtration rate (Schwartz estimate) was significantly higher in the Tac group (62+/-20 ml/min per 1.73 m(2), n=84) than in the CyA group (56+/-21 ml/min per 1.73 m(2), n=74, P=0.03). The most frequent adverse events during the first 6 months were hypertension (68.9% vs. 61.3%), hypomagnesemia (34.0% vs. 12.9%, P=0.001), and urinary tract infection (29.1% vs. 33.3%). Statistically significant differences ( P<0.05) were observed for diarrhea (13.6% vs. 3.2%), hypertrichosis (0.0% vs. 7.5%), flu syndrome (0.0% vs. 5.4%), and gum hyperplasia (0.0% vs. 5.4%). In previously non-diabetic children, the incidence of long-term (>30 days) insulin use was 3.0% (Tac) and 2.2% (CyA). Post-transplant lymphoproliferative disease was observed in 1 patient in the Tac group and 2 patients in the CyA group. In conclusion, Tac was significantly more effective than CyA microemulsion in preventing acute rejection after renal transplantation in a pediatric population. The overall safety profiles of the two regimens were comparable.</description><subject>Acute Disease</subject><subject>Adolescent</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Cyclosporine - therapeutic use</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Graft Rejection</subject><subject>Graft Survival</subject><subject>Humans</subject><subject>Immunomodulators</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Kidney Transplantation</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Tacrolimus - therapeutic use</subject><issn>0931-041X</issn><issn>1432-198X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNpdkF1L5TAQhoOs6PHjB3gjRdC7rjNNm49LEXUXhAVROHchTVOItM0x0wr6642cA8JeDeR93mHyMHaG8BsB5DUB1EKWAFiC1E2p99gKa16VqNX6F1uB5jmpcX3IjoheAUA1ShywQ0TdCFWrFVs_2amLY_j0XTGnYIci9sVsXYpDGBcq3n2iPNyHGyJtYgpTMYac-nEZKMSpyA_JT7k3JzvRZrDTbOccnLD93g7kT3fzmL3c3z3f_ikf_z38vb15LF2lxFxqK1qQQvlOyrYTfVO3ulVgoatFJlTTNQJlpcBph6Jt0XlshXdeYe8r2fNjdrXdu0nxbfE0mzGQ80M-xMeFjESBWCNk8OI_8DUuKV9OpqoqLpBzzBBuofxFouR7s0lhtOnDIJhv52br3GTn5tu50blzvlu8tKPvfho7yRm43AGWnB36LMoF-uF4w2WtOf8CTjmLUA</recordid><startdate>20020301</startdate><enddate>20020301</enddate><creator>TROMPETER, Richard</creator><creator>FILLER, Guido</creator><creator>KLARE, Bernd</creator><creator>ZACCHELLO, Graziella</creator><creator>BREKKE, Inge Bjorn</creator><creator>MCGRAW, Mary</creator><creator>PERNER, Ferenc</creator><creator>GHIO, Lucian</creator><creator>BALZAR, Egon</creator><creator>FRIMAN, Styrbjörn</creator><creator>GUSMANO, Rosanna</creator><creator>STOLPE, Jochen</creator><creator>WEBB, Nicholas J. 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A</au><au>WATSON, Alan R</au><au>MILFORD, David V</au><au>TYDEN, Gunnar</au><au>GRENDA, Ryszard</au><au>JANDA, Jan</au><au>HUGHES, David</au><au>EHRICH, Jochen H. H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation</atitle><jtitle>Pediatric nephrology (Berlin, West)</jtitle><addtitle>Pediatr Nephrol</addtitle><date>2002-03-01</date><risdate>2002</risdate><volume>17</volume><issue>3</issue><spage>141</spage><epage>149</epage><pages>141-149</pages><issn>0931-041X</issn><eissn>1432-198X</eissn><coden>PENED3</coden><abstract>This study was undertaken to compare the efficacy and safety of tacrolimus (Tac) with the microemulsion formulation of cyclosporin (CyA) in children undergoing renal transplantation. A 6-month, randomized, prospective, open, parallel group study with an open extension phase was conducted in 18 centers from nine European countries. In total, 196 pediatric patients (<18 years) were randomly assigned (1:1) to receive either Tac ( n=103) or CyA microemulsion ( n=93) administered concomitantly with azathioprine and corticosteroids. The primary endpoint was incidence and time to first acute rejection. Baseline characteristics were comparable between treatment groups. Tac therapy resulted in a significantly lower incidence of acute rejection (36.9%) compared with CyA therapy (59.1%) ( P=0.003). The incidence of corticosteroid-resistant rejection was also significantly lower in the Tac group compared with the CyA group (7.8% vs. 25.8%, P=0.001). The differences were also significant for biopsy-confirmed acute rejection (16.5% vs. 39.8%, P<0.001). At 1 year, patient survival was similar (96.1% vs. 96.6%), while 10 grafts were lost in the Tac group compared with 17 graft losses in the CyA group ( P=0.06). At 1 year, mean glomerular filtration rate (Schwartz estimate) was significantly higher in the Tac group (62+/-20 ml/min per 1.73 m(2), n=84) than in the CyA group (56+/-21 ml/min per 1.73 m(2), n=74, P=0.03). The most frequent adverse events during the first 6 months were hypertension (68.9% vs. 61.3%), hypomagnesemia (34.0% vs. 12.9%, P=0.001), and urinary tract infection (29.1% vs. 33.3%). Statistically significant differences ( P<0.05) were observed for diarrhea (13.6% vs. 3.2%), hypertrichosis (0.0% vs. 7.5%), flu syndrome (0.0% vs. 5.4%), and gum hyperplasia (0.0% vs. 5.4%). In previously non-diabetic children, the incidence of long-term (>30 days) insulin use was 3.0% (Tac) and 2.2% (CyA). Post-transplant lymphoproliferative disease was observed in 1 patient in the Tac group and 2 patients in the CyA group. In conclusion, Tac was significantly more effective than CyA microemulsion in preventing acute rejection after renal transplantation in a pediatric population. The overall safety profiles of the two regimens were comparable.</abstract><cop>Heidelberg</cop><pub>Springer</pub><pmid>11956848</pmid><doi>10.1007/s00467-001-0795-9</doi><tpages>9</tpages></addata></record> |
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| ispartof | Pediatric nephrology (Berlin, West), 2002-03, Vol.17 (3), p.141-149 |
| issn | 0931-041X 1432-198X |
| language | eng |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Acute Disease Adolescent Biological and medical sciences Child Cyclosporine - therapeutic use Female Follow-Up Studies Graft Rejection Graft Survival Humans Immunomodulators Immunosuppressive Agents - therapeutic use Kidney Transplantation Male Medical sciences Pharmacology. Drug treatments Prospective Studies Tacrolimus - therapeutic use |
| title | Randomized trial of tacrolimus versus cyclosporin microemulsion in renal transplantation |
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