Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients Converted From Twice-daily Tacrolimus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Dose-normalized Trough
研究概览
简要总结
Compare the difference in dose-normalized trough and total daily dose necessary to reach the steady state therapeutic goal after conversion from tacrolimus IR to Astagraf XL® in African American kidney transplant recipients.
详细描述
The purpose of this study is to compare the difference in medication dosage and total daily dose necessary of Astagraf XL® in order to reach therapy goal, when taken with other medications that are routinely used for kidney transplantation, which may stop the development of a substance that can cause long-term damage to the transplanted kidney. African American kidney transplant patients aged 18 and above who are underwent a kidney transplant are eligible to participate. The duration of the study is 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years of age
- •Signed informed consent
- •African American race
- •History of a solitary renal transplant
- •Stable tacrolimus dose for at least 2 weeks prior to randomization
排除标准
- •A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
- •Currently enrolled in an investigational drug trial
- •History of a non-renal organ transplant
- •History of acute cellular rejection within 1 month prior to randomization
- •An increase in serum creatinine by > 20% in the 2 weeks prior to randomization
- •Maintenance immunosuppression that does not consist of tacrolimus IR given twice daily, mycophenolate mofetil > 1000mg TDD or mycophenolate sodium > 720mg TDD, and prednisone ≥ 5mg daily
研究组 & 干预措施
Conversion Arm
Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily
干预措施: Tacrolimus Extended Release Capsule (Drug)
Conversion Arm
Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily
干预措施: Mycophenolate mofetil (Drug)
Conversion Arm
Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily
干预措施: Prednisone (Drug)
Conversion Arm
Tacrolimus Extended Release Capsule (goal 5 - 12ng/mL) + Mycophenolate Mofetil ≥500mg twice a day OR Mycophenolate Sodium ≥360mg twice a day+ prednisone ≥ 5mg Daily
干预措施: Mycophenolate Sodium (Drug)
结局指标
主要结局
Dose-normalized Trough
时间窗: Baseline to 3 months post-conversion
Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL®
次要结局
- Weight-Based Dose Requirement(Baseline to 3 months post conversion)
- Dose Modifications(Baseline to 3 months post conversion)
- Total Daily Dose(Baseline to 3 months post conversion)
- Number of Days to Reach Therapeutic Trough Goal(Baseline to 3 months post conversion)
研究者
James N. Fleming
Principal Investigator
Medical University of South Carolina