跳至主要内容
临床试验/NCT00867386
NCT00867386已完成不适用

Desensitization for Highly Sensitized Recipients of Pancreas Transplantation

Northwestern University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Success of surgical engraftment.

研究概览

简要总结

This is an observational study for patients with type 1 diabetes, whom are already scheduled to have desensitization treatment to help increase the chance of receiving a pancreas transplant.The study staff will be looking at medical records in order to collect past, present and future information for each subject's medical condition and/or transplant. There are no additional study tests, procedures or devices needed for our analysis.

详细描述

Please note that this study is observational. The treatment of each patient will be at the discretion of the care physician. The study investigators will ONLY be performing data collection and analysis.

Post transplant all patients will receive one additional cycle of plasma exchange with a moderate dose of Intravenous Immunoglobulin (IVIg) (0.4 mg/Kg). Antibody titers will be monitoring prior to plasma exchange and immediately following the treatment. At this point, since donor antigens are known, only antibodies to these antigens will be tested to minimize cost. We anticipate that in some patients, especially if the original titer of donor-specific antibody (DSA) was high (> 1:128), a rise in DSA will be observed following transplant. If indeed DSA will be present, additional monitoring will be initiated and the patient will be treated further with plasma exchange/IVIg cycles, with antibody monitoring before and immediately after each cycle. If no DSA are detected, patients will be monitoring on a every other day schedule for the first week; weekly for the next 3 weeks and monthly up to 6 months post transplant. Additional testing will be performed in the event of any clinical evidence of graft dysfunction, or following sever infection events.

Patient will be followed to 12 month post transplant or until one of the end points is reached:

  1. pancreas graft failure: defined by return of hyperglycemia and resume of insulin therapy;
  2. patient death due to all causes with functioning graft

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

入选标准

  • Pancreas transplant recipients with elevated panel reactive antibody levels of >50% and who have received desensitization treatment and subsequently receive their transplantation at Northwestern Memorial Hospital (NMH).

排除标准

  • No Exclusion criteria exist.

结局指标

主要结局

Success of surgical engraftment.

时间窗: Post-operative day 1

This is measured by standard blood flow perfusion scan. Adequate blood flow is demonstrated by appropriate radioactive tracer uptake by the pancreas allograft. Lack of blood flow will prompt immediate surgical intervention.

Track the improvement of glycemic control.

时间窗: Standard-of-care labs throughout duration of study

Standard of care laboratory values measured routinely include: fasting and post-prandial glucose determination, serum C-peptide levels, improvement of Hemoglobin (A1C) levels post-transplant.

Rejection free graft survival.

时间窗: 12 Month follow-up from baseline

Serum amylase \& lipase measured. Rising levels/aberrant glycemic control may indicate allograft rejection. Treatment - pancreas allograft rejection: 1) diagnosed by pancreas allograft biopsy; 2) if rejection, staining for C4d, repeat to DSA to determine rejection (acute antibody meditated humoral vs. acute cellular); 3) acute humoral rejection treated w/plasma exchange, then by Intravenous Immunoglobulin (IVIg) (0.5 gm/kg) every other day, daily polyclonal anti-thymocyte globulin (ATG) at 1.25 mg/kg. Treatment duration based on clinical response. Baseline immunosuppressive medications maintained during treatment.

Patient and graft survival.

时间窗: At 12 Month follow-up

Patient and graft survival will be calculated at this time.

次要结局

  • Tracking infection risks(Standard of care benchmarks through 12 months)
  • Bleeding complications(At 12 Months follow-up time points)
  • Reversal or halting of diabetic complications(0, 6, 12, 18, 24 Months)

研究者

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

Xunrong Luo

Associate Professor in Medicine-Nephrology, Microbiology-Immunology and Surgery-Organ Transplantation

Northwestern University

研究点 (1)

Loading locations...

相似试验