{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T08:19:36Z","timestamp":1770970776899,"version":"3.50.1"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2013,3,7]],"date-time":"2013-03-07T00:00:00Z","timestamp":1362614400000},"content-version":"vor","delay-in-days":2622,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2006,1]]},"abstract":"<jats:p>This multicenter, open\u2010label study compared the efficacy, safety, and pharmacokinetic parameters of sirolimus (rapamycin) tablet and liquid formulations for prevention of efficacy failure. A total of 477 renal allograft recipients were randomly assigned (1:1) to receive either tablet or solution formulations of sirolimus for 12 months, plus cyclosporine (CsA) and steroids. Pharmacokinetic parameters were analyzed based on trough concentrations and 24\u2010hour pharmacokinetic profiles. There were no significant differences in efficacy failure at 3 or 12 months between tablet and solution groups. Graft survival, patient survival, rate of first biopsy\u2010confirmed acute rejection, time to and severity of acute rejection, and laboratory parameters were not significantly different between groups. Mean steady\u2010state sirolimus and CsA pharmacokinetic parameters on days 30 and 90 were not significantly different by formulation, except for longer sirolimus t<jats:sub><jats:italic>max<\/jats:italic><\/jats:sub>after tablet administration. Multivariate logistic regression analysis indicated that low sirolimus C<jats:sub><jats:italic>min, TN<\/jats:italic><\/jats:sub>and more human leukocyte antigen mismatches were predictors of acute rejection. The tablet and solution formulations of sirolimus demonstrated therapeutic equivalence.<\/jats:p>","DOI":"10.1177\/0091270005282628","type":"journal-article","created":{"date-parts":[[2006,1,5]],"date-time":"2006-01-05T23:48:39Z","timestamp":1136504919000},"page":"76-87","source":"Crossref","is-referenced-by-count":24,"title":["A Comparative Study of Sirolimus Tablet Versus Oral Solution for Prophylaxis of Acute Renal Allograft Rejection"],"prefix":"10.1002","volume":"46","author":[{"given":"Timothy H.","family":"Mathew","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Van Buren","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barry D.","family":"Kahan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khalid","family":"Butt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sundaram","family":"Hariharan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James J.","family":"Zimmerman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"Rapamune 309 Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,3,7]]},"reference":[{"key":"e_1_2_6_2_2","first-page":"1","article-title":"The UNOS Scientific Renal Transplant Registry: ten years of kidney transplants","author":"Cecka JM","year":"1997","journal-title":"Clin Transpl."},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200003023420901"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/00000658-199112000-00007"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199606150-00006"},{"key":"e_1_2_6_6_2","doi-asserted-by":"crossref","first-page":"328","DOI":"10.1111\/j.1399-0012.1994.tb00263.x","article-title":"Acute rejection episodes: best predictor of long\u2010term primary cadaveric renal transplant survival","volume":"8","author":"Ferguson R","year":"1994","journal-title":"Clin Transplant."},{"key":"e_1_2_6_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0009-9120(98)00045-9"},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/0092-8674(94)90570-3"},{"key":"e_1_2_6_9_2","doi-asserted-by":"publisher","DOI":"10.1034\/j.1399-0012.1999.130301.x"},{"key":"e_1_2_6_10_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199911270-00016"},{"key":"e_1_2_6_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)02480-6"},{"key":"e_1_2_6_12_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-200101270-00019"},{"key":"e_1_2_6_13_2","volume-title":"Physicians\u2019 Desk Reference.","year":"2004"},{"key":"e_1_2_6_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-200109150-00007"},{"key":"e_1_2_6_15_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.TP.0000074360.62032.39"},{"key":"e_1_2_6_16_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.ASN.0000113248.59077.76"},{"key":"e_1_2_6_17_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1432-2277.2004.00052.x"},{"key":"e_1_2_6_18_2","doi-asserted-by":"publisher","DOI":"10.1177\/0091270003257227"},{"key":"e_1_2_6_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0378-4347(98)00371-5"},{"key":"e_1_2_6_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(00)89022-0"},{"key":"e_1_2_6_21_2","volume-title":"SAS User's Guide: Statistics.","author":"SAS Institute, Inc","year":"1985"},{"key":"e_1_2_6_22_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199102000-00041"},{"key":"e_1_2_6_23_2","doi-asserted-by":"publisher","DOI":"10.1080\/00401706.1962.10490038"},{"key":"e_1_2_6_24_2","doi-asserted-by":"publisher","DOI":"10.1034\/j.1600-6143.2002.20610.x"},{"key":"e_1_2_6_25_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199203000-00002"},{"key":"e_1_2_6_26_2","doi-asserted-by":"publisher","DOI":"10.1038\/ki.1996.417"},{"key":"e_1_2_6_27_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1432-2277.1994.tb01225.x"},{"key":"e_1_2_6_28_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199904150-00017"},{"key":"e_1_2_6_29_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-200004150-00009"},{"key":"e_1_2_6_30_2","doi-asserted-by":"publisher","DOI":"10.1034\/j.1600-6143.2002.20507.x"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1177\/0091270005282628","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,6]],"date-time":"2025-01-06T23:11:42Z","timestamp":1736205102000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1177\/0091270005282628"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2006,1]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2006,1]]}},"alternative-id":["10.1177\/0091270005282628"],"URL":"https:\/\/doi.org\/10.1177\/0091270005282628","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2006,1]]}}}