NCT01896089Unknown不适用
Prospective, Multicenter, Observational Registry Study to Determine if Enrollment in a Regional Kidney Paired Donor Exchange Program Improves the Overall Rate of Kidney Transplantation in Sensitized Patients, and Sensitized Patients Undergoing Desensitization Treatments.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program
研究概览
简要总结
This is a prospective, multi-center, observational study to determine if a combination of desensitization and enrollment in a regional kidney paired donor (KPD) exchange program improves the overall rate of kidney transplantation in sensitized patients.
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
- 否
入选标准
- •A. Potential Recipients must meet the following inclusion criteria:
- •Willing and able to sign an informed consent form
- •Must be at least 18 years old
- •Meet all recipient selection criteria of the transplant center
- •Listed on the deceased donor kidney waiting list for renal transplant at a participating center
- •Potential recipients must:
- •Group 1: have one or more medically suitable donors who are ABO incompatible or HLA incompatible (defined as positive serologic cross-match); or
- •Group 2: have a medically suitable donor that is otherwise deemed incompatible due to age, size, or other mismatch by their respective transplant center; or
- •Group 3: be listed on the deceased donor waiting list for ≥ one year without an identifiable living donor and have a PRA% ≥ 60%
- •B. Potential Living Donors must meet the following inclusion criteria:
- •Must provide informed consent in accordance with the process outlined in the Informed Consent Requirements Section of the KPD Program Manual of Operations
- •Must be at least 18 years old
- •Meet all living donor selection criteria of the transplant center
- •Meet the evaluation requirements set forth in the Living Donor Evaluation Section of the KPD Program Operational Guidelines
排除标准
- •C. Recipients
- •Do not meet selection criteria of the transplant center
- •Eligible compatible donor at the time of enrollment
- •Inactive (not eligible to receive a kidney) on the deceased donor waitlist
- •Pregnant or breast feeding
- •Unwilling or unable to provide informed consent
- •Have identified barriers to donation as set forth in the Living Donor Evaluation Section of the KPD Program Manual of Operations (Appendix A)
- •Must not be currently listed as a potential living donor for any other recipient registered in the KPD system
- •Pregnant or breast feeding
结局指标
主要结局
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program
时间窗: 24 months
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program will be summarized.
次要结局
- Overall number of kidney transplants per center/region(24 months)
研究者
研究点 (2)
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