TACROLIMUS WITH STEROIDS AND STANDARD DACLIZUMAB VERSUS STEROID-FREE TACROLIMUS

含类固醇的他克莫司和标准达利珠单抗与不含类固醇的他克莫司

• 批准号: 7605252
• 负责人: Minnie M Sarwal
• 金额: $ 0.06万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605252
• 关键词: Biological Availability; Blood Cells; Child; Childhood; Comparative Study; Computer Retrieval of Information on Scientific Projects Database; Daclizumab; Dose; Drug Kinetics; Enrollment; Funding; Grant; Immunosuppression; Immunosuppressive Agents; Institution; Kidney Transplantation; Mycophenolate Mofetil/Tacrolimus; Prograf; Protocols documentation; Randomized; Research; Research Personnel; Resources; Roche brand of daclizumab; Safety; Source; Standards of Weights and Measures; Steroids; Tacrolimus; Therapeutic immunosuppression; Transplant Recipients; Treatment Protocols; United States National Institutes of Health; Week; base; fluorouracil/methotrexate/mitoxantrone protocol; mycophenolate mofetil

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. BACKGROUND AND SIGNIFICANCE: Protocol SNS01 is a randomized (1:1) comparative study of traditional immunosuppressive regimen (5 doses of Zenapax induction over an 8-week period, tacrolimus, mycophenolate mofetil and steroids) vs. steroid-free immunosuppressive regimen (9 doses of Zenapax induction over a 6-month period, tacrolimus and mycophenolate mofetil). Studies have shown that both mycophenolate mofetil (CellCept, MMF) and tacrolimus (Prograf) are absorbed in blood cells. However, the pharmacokinetics in children we do not completely understood. SPECIFIC AIMS: The primary objective of the SNS01 Protocol is to compare the safety and efficacy of steroid-free immunosuppression, given in combination with tacrolimus (Prograf), mycophenolate mofetil (CellCept) and daclizumab (Zenapax) induction with steroid-based immunosuppression. The specific aim of the MPA and Tacrolimus PK Sub-Study is to determine the bioavailability of tacrolimus and mycophenolate mofetil in pediatric renal transplant patients enrolled in Protocol SNS01.

这个子项目是众多研究子项目之一