Calcineurin Inhibitors to Belatacept Switch Study to Prevent the Progression of Kidney Disease in Pancreas Transplant Alone Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Serum Creatinine at Year 1
研究概览
简要总结
Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. One of the challenges following pancreas transplant is that a patient can develop kidney damage from one of their antirejection medicines, tacrolimus. The objective of this study is to substitute a new antirejection medicine which does not cause kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus related kidney damage to slow the progression of kidney disease.
详细描述
Nephrotoxicity is a major complication of current immunosuppression regimens used in transplantation. Pancreas transplantation has been increasedly performed to manage labile diabetes mellitus during the last few decades and survival rates of pancreatic grafts are improving. One of the challenges that is faced following pancreas transplantation alone are pathologic changes from diabetes frequently seen in native kidneys in the pancreas transplant recipients. High levels of calcineurin inhibitors (CNI) have been identified as risk factors for decline in kidney function and progression to end-stage renal disease. The objective of this trial is to take subjects who have biopsy proven CNI toxicity off of their CNI and begin belatacept, which is not a CNI.
The hypothesis is by switching the pancreas transplant subject with documented CNI kidney toxicity to belatacept will slow the progression of chronic kidney disease.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pancreas transplant alone recipients
- •EBV IgG positive
- •Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy
- •Maintained on a regimen of tacrolimus, sirolimus, mycophenolate
排除标准
- •EBV IgG negative
- •Not maintained on an immunosuppression regimen that contains tacrolimus
- •Unable or unwilling to give informed consent
- •Active infection
- •History of malignancy post transplant
- •Glomerular filtration rate < 15 mL/min
研究组 & 干预措施
belatacept
Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.
Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
干预措施: Belatacept (Drug)
结局指标
主要结局
Serum Creatinine at Year 1
时间窗: 1 year
Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.
Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)
时间窗: Baseline and 1 year
Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept
次要结局
- Change From Baseline Serum Hemoglobin A1c(Baseline and 1 year)
- Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.(1 Year)
- Number of Participants With Pancreas Transplant Rejection(1 year)
研究者
Asif Sharfuddin
Asif A Sharfuddin, MD
Indiana University