Surveillance Registry Of Sirolimus Use In Recipients Of Kidney Allograft From Expanded Criteria Donors (ECD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
研究概览
简要总结
The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppressive treatment with sirolimus.
详细描述
pilot study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older.
- •Patients who received a renal transplant (primary, secondary, tertiary, etc.) without pancreas, from Expanded Criteria Donors (ECD), 3 months prior and no later than 1 year at the time of study enrollment.
- •Patients who provided informed consent.
- •Patients without sirolimus as base therapy.
排除标准
- •Patients who are unwilling or unable to provide informed consent or who lack a legal guardian or designee able to provide consent on their behalf.
- •Patients who are unable to complete the study.
- •Patients who are participating in another clinical trial during the last 6 months.
- •Pregnant or lactating patients.
研究组 & 干预措施
A
干预措施: Sirolimus (Drug)
结局指标
主要结局
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
时间窗: Baseline
The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.
次要结局
- Probability of Graft Survival(Month 12)
- Body Weight(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Probability of no Acute Rejection(Month 12)
- Probability of Participant Survival(Month 12)
- Average Dose of Immunosuppressive Drugs Administered(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Average Blood Level of Immunosuppressive Drugs Administered(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Average Creatinine Clearance(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Average Proteinuria(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy(Baseline up to Month 12)
- Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy(Baseline up to Month 12)
- Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events(Baseline up to Month 12)
- Body Mass Index(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Number of Participants With Body Temperature(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Blood Pressure(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Pulse Rate(Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53)
- Percentage of Participants With Physical Abnormalities(Baseline up to Month 12)
- Percentage of Participants With Adverse Events(Baseline up to Month 12)
- Percentage of Participants With Serious Adverse Events(Baseline up to Month 12)
- Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities(Baseline up to Month 12)
- Percentage of Participants With Clinically-Significant Radiological Abnormalities(Baseline up to Month 12)