A 12 Month, Single-center, Non-randomized, Open-label Study of Outcomes of Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores in de Novo Renal Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Renal Function
研究概览
简要总结
This will be a pilot study to investigate the use of belatacept (BMS) therapy in kidney transplant patients who have a MAPI score of greater than or equal to 8. The MAPI (Maryland Aggregate Pathology Index) score is a preimplantation donor scoring system which has five histopathological parameters that impact long-term kidney outcomes. Many kidney transplant recipients use calcineurin inhibitors (CNIs) as one of their anti-rejection medi cations. Kidney function may be affected by anti-rejection medications known as calcineurin inhibitors (CNIs). Sometimes CNIs can lead to toxicities and eventually loss of the kidney or episodes of chronic allograft nephropathy (CAN). Avoiding CNI immunosuppression and using belatacept therapy (BMS) instead, may be associated with improved kidney transplant outcomes.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female renal recipients 18-70 years of age undergoing primary kidney transplantation.
- •Recipients of deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death) with MAPI score ≥
- •Cold ischemic time less than 40 hours at time of reperfusion.
- •Negative serum pregnancy test for female patients.
- •Patients who can understand the purposes and risks of the study, provide informed consent, and can comply with the treatment and follow-up requirements.
排除标准
- •Cold ischemic time (CIT) > 40 hours
- •Patients who are sensitized with current PRA>40%, ABO incompatible transplants, or T, or B cell crossmatch positive transplant.
- •Patients without antibody to EBV
- •Patients receiving multiple organ transplants.
- •Patients unable to take oral medication at time of randomization
- •Patient with a history of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of carcinoma in situ
- •Patients who tested positive for HIV, Hepatitis C or Hepatitis B surface antigen.
- •Recipients of organs from donors who test positive for HIV, Hepatitis C or Hepatitis B surface antigen
- •Patients with a clinically significant systemic infection within 30 days prior to transplant
- •Patients who have cardiac failure at time of screening or any other severe cardiac disease as determined by the investigator
- •Patients with abnormal laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study.
- •Females, pregnant or lactating, or are of childbearing potential unwilling to use an effective means of contraception or are planning to become pregnant.
- •Patient with active tuberculosis infection
研究组 & 干预措施
Belatacept therapy
20 Patients receiving belatacept based immunosuppressive protocol for 12 months post-transplantation.
干预措施: Belatacept (Drug)
结局指标
主要结局
Renal Function
时间窗: 12 months
To evaluate renal function in Belatacept treated recipients of intermediate risk MAPI score allografts in terms of estimated glomerular filtration rate (eGFR, calculated using the MDRD formula) assessed at 12 months. The 12 month eGFR will be compared to existing cohorts of calcineurin inhibitor treated patients with MAPI scores above 8.
次要结局
- Rejection rate(12 months)
- Graft survival(12 months)
- MAPI biopsy score(12 months)
- Patient survival(12 months)
研究者
Rolf Barth
Principal Investigator
University of Maryland