A Prospective, Randomized, Open-Label, Pilot Study To Compare The Effect On Carotid Atherosclerosis Of A Tacrolimus-Based Regimen With Conversion From A Tacrolimus- To A Sirolimus-Based Regimen At 3-4 Months Post-Transplant In De Novo Renal Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
研究概览
简要总结
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.
详细描述
A decision to terminate the study was taken in November 2011 and a communication to that effect sent to all participating sites on November 18. All sites were asked to have patients returned to the sites and have all end of study procedures performed by Dec 31, 2011.
The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint. The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one of the following characteristics:
- •History of dialysis for at least 3 years.
- •History of diabetes for at least 5 years.
- •Hypertension or ischemic nephropathy as a cause of the end stage renal disease or loss of the first transplant.
- •History of coronary artery disease, stroke, myocardial infarction, or amputation for vascular disease.
排除标准
- •History of malignancy within the last 5 years (except adequately treated skin cancer).
- •Recipients of non-renal organ transplant.
- •Active gastrointestinal disease that may interfere with drug absorption.
- •Active HIV, hepatitis B or C infection.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
1
Tacrolimus + MMF + Steroids
干预措施: tacrolimus (Drug)
1
Tacrolimus + MMF + Steroids
干预措施: mycophenolate mofetil (Drug)
1
Tacrolimus + MMF + Steroids
干预措施: prednisone (Drug)
2
Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant
干预措施: sirolimus (Drug)
2
Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant
干预措施: tacrolimus (Drug)
2
Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant
干预措施: mycophenolate mofetil (Drug)
2
Tacrolimus + MMF + Steroids with conversion from Tacrolimus to Sirolimus at 3-4 months post-transplant
干预措施: prednisone (Drug)
结局指标
主要结局
Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
时间窗: Pre-conversion baseline and 12 months post-transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus \[-\] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
TPV at Pre-conversion Baseline
时间窗: Pre-conversion baseline
TPV is the sum of the assessment in left and right distal common carotid arteries.
次要结局
- CIMT at Pre-conversion Baseline(Pre-conversion baseline)
- Number of Participants Who Used Anti-hypertensive Medications(From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant)
- Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant(Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant(Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Number of Participants Who Used Lipid Lowering Therapies(From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant)
- Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant(Pre-conversion baseline, and 18, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant(Pre-conversion baseline, 12, and 24 months post-transplant)
- Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)
- Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant(Pre-conversion baseline, 12, 24 and 36 months post-transplant)