CONTINUING RETROSPECTIVE AND PROSPECTIVE STUDIES BASED ON DETAILED CLINICAL

基于详细临床的持续回顾性和前瞻性研究

• 批准号: 7688848
• 负责人: ARTHUR J MATAS
• 金额: --
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7688848
• 关键词: Address; Adverse effects; Animals; Applications Grants; Caring; Chronic; Clinical; Clinical Research; Clinical Trials; Communities; Data; Data Analyses; Databases; Disease; Drug toxicity; Future; Grant; Immunologics; Immunosuppressive Agents; Joints; Laboratories; Lead; Morbidity - disease rate; Observational Study; Organ; Organ Transplantation; Outcome; Patient Preferences; Pharmaceutical Preparations; Physicians; Progress Reports; Prospective Studies; Protocols documentation; Quality of life; Randomized; Recurrent disease; Rehabilitation therapy; Renal function; Reporting; Research Personnel; Resources; Risk; Risk Factors; Solid; Subgroup; Thrombosis; Transplant Recipients; Transplantation; Upper arm; base; follow-up; improved; man; meetings; prevent; wasting

Our preliminary data addressed some of our short-term end-points. We plan long-term follow-up to determine the impact of each of these immunosuppressive protocols on long-term kidney function. We will continue to do intention-to-treat analyses. However, we will also analyze subgroups that remain in their original randomized arm. One of the unexpected limitations of this study has been the high number of recipients that have not continued on one or both of the original study drugs. The multiple reasons for changes include inability to achieve study drug levels, AR, side effects, changes in local physician, and patient preference. Of note, national data show that a high percentage of transplant recipients have one of more of their immunosuppressive medications changed in the first 2 transplant years (32).

我们的初步数据说明了我们的一些短期终点。我们计划进行长期随访，以确定每种免疫抑制方案对长期肾功能的影响。 我们将继续进行意向治疗分析。然而，我们也将分析保留在其原始随机臂中的子组。这项研究的一个意想不到的限制是，大量的受试者没有继续服用一种或两种原始研究药物。变化的多种原因包括无法达到研究的药物水平、AR、副作用、当地医生的变化以及患者的偏好。值得注意的是，国家数据显示，高比例的移植受者患有一种或多种 他们的免疫抑制药物在移植的前两年发生了变化(32例)。