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临床试验/NCT01875224
NCT01875224Unknown4 期

Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression

University of Arizona1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
32
试验地点
1
主要终点
Increased insulin sensitivity

研究概览

简要总结

This study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with NODAT will be approached with the opportunity to participate in this study. If they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). If a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. The control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of NODAT in all patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Written informed consent must be given by patient.
  • Adult patients between age 18 and 65
  • Thymoglobulin induction at the time of transplant
  • Patient must be Epstein-Barr Virus seropositive

排除标准

  • Patient who received an blood type incompatible transplant, or with T-cell or B-cell positive crossmatch
  • Patients with Hepatitis B, Hepatitis C, HIV or a clinically significant systemic infection within 30 days prior to transplant
  • History of stroke, severe cardiac disease or cardiac failure

研究组 & 干预措施

Belatacept and CellCept

Experimental

Belatacept administered based on patient's weight once a month after initial period, Cellcept taken twice daily.

干预措施: Belatacept (Drug)

Tacrolimus and CellCept

Active Comparator

Tacrolimus and CellCept taken twice daily based on patient response.

干预措施: Tacrolimus (Drug)

结局指标

主要结局

Increased insulin sensitivity

时间窗: 12 months

Increase in insulin sensitivity (HOMA-S) as calculated below: FIRI = fasting plasma insulin level FPG = fasting plasma glucose level HOMA-S (insulin sensitivity) is calculated as 22.5 / (FIRI \* FPG)

Decreased insulin resistance

时间窗: 12 months

Decreased insulin resistance (HOMA-IR) as measured below: FIRI = fasting plasma insulin level FPG = fasting plasma glucose level HOMA IR (insulin resistance) is calculated as (FIRI \* FPG) / 22.5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruce Kaplan

Chief of Abdominal Transplantation

University of Arizona

研究点 (1)

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