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临床试验/NCT02758288
NCT02758288撤回不适用

BK Viremia and BK Virus Nephropathy Post Kidney Transplant Comparison of New Practices With Traditional Approach: A Combined Retrospective Chart Review and Prospective Observational Study

Loma Linda University1 个研究点 分布在 1 个国家开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Kidney function to compare effectiveness of a new care protocol for the treatment of BK viremia (BK PCR viral load over 500 copy) and BKVAN (confirmed by kidney biopsy) with a similar cohort treated with traditional methods.

研究概览

简要总结

The investigator's aim in this study is to evaluate the impact of a new standard of care protocol for the treatment of BK viremia and nephropathy (BKVAN), which includes switching from Tacrolimus to equivalent dose of Cyclosporine in patients who have been diagnosed with BK viremia or BKVAN based on their viral load, overall graft function (estimated glomerular filtration rate), acute rejection, and rate of graft loss due to rejection or BKVAN.

详细描述

This study will be a combined retrospective chart review and prospective observational study. This will be a single center project that will take place at Loma Linda University Transplant Institute. All adult kidney recipients who are determined to have BK viremia with a BK PCR viral load over 500 copy post-transplant and meet the inclusion criteria but no exclusion criteria will be enrolled and observed per study protocol.

All kidney transplant recipients are routinely assessed for BK virus nephropathy and viremia post transplant as part of their standard care. Patients with BK viremia or BK virus nephropathy will have adjustments in their immunosuppressive medication based on current guidelines and recommendations which include reduction in immunosuppression, treatment with medications with antiviral activity (Cidofovir, Ciprofloxacin, Leflunomide, IVIG) or switching from a Tacrolimus (Prograf)-based regimen to a Cyclosporine-based regimen. Retrospectively, the investigator will collect data on patients who have been diagnosed with BK viremia or BK virus nephropathy and have had such a management in past 66 months (from 1/1/2010 till 06/30/2015). Prospectively, the investigator will enroll and collect data on patients who will be treated for BK viremia or BK virus nephropathy.

As standard of care, all kidney transplant recipients will be seen routinely on weekly-biweekly basis in post-transplant clinic for up to 3 months then every 3 months for up to a year and yearly thereafter. All kidney transplant recipients will be monitored for BK viremia by having blood PCR tested on a monthly basis at 1, 2, 3, 6, and 12 months after transplant. Also, all patients post-kidney transplant will be tested for BK viremia if there is an acute rise in their creatinine.

研究设计

研究类型
Observational
观察模型
Other
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

  • Age ≥ 18 years
  • Recipient of kidney or combined kidney and pancreas
  • BK viremia confirmed with blood PCR test with viral load over 500
  • BK virus nephropathy confirmed by kidney biopsy

排除标准

  • Recipient of combined organ transplant except kidney and pancreases
  • Patient age < 18 years
  • If patient does not consent for kidney biopsy
  • Currently on treatment for acute rejection
  • Patients with HIV, Hep C or Hep B infection
  • Patients who are on other immunosuppression beside our standard regimen which includes Prograf, cellcept / Myfortic and prednisone

结局指标

主要结局

Kidney function to compare effectiveness of a new care protocol for the treatment of BK viremia (BK PCR viral load over 500 copy) and BKVAN (confirmed by kidney biopsy) with a similar cohort treated with traditional methods.

时间窗: 12 months

次要结局

  • Rate of BK nephropathy in both treatment groups confirmed by kidney biopsy(24 months)
  • Rate of graft loss in both group as determined by elevated creatinine level and kidney biopsy(24 months)
  • Estimated glomerular filtration rate (eGFR) at start of the study (0) , 3, 6, 12 and 24 months between two groups(3, 6, 12, 24 months)
  • Rate of acute cellular or humoral rejection in both treatment groups confirmed by kidney biopsy(24 months)

研究者

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

Amir Abdipour, MD

Assistant Professor of Medicine

Loma Linda University

研究点 (1)

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