A Prospective, Long-term Confirmatory Follow up Trial in Highly Sensitized Patients Treated With Imlifidase or Standard of Care in the ConfIdeS (20-HMedIdeS-17) Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 14
- 主要终点
- Proportion of patients alive and free of dialysis at 3 years
研究概览
简要总结
The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to enable kidney transplantation in clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177).
详细描述
This is an observational follow-up study subsequent to the ConfIdeS study (20-HMedIdeS-17, NCT04935177) in highly sensitized patients who were randomized to imlifidase or SoC desensitization prior to kidney transplantation with a deceased donor graft, or, if SoC perioperative treatment has been deemed not appropriate, wait for a more immunologically compatible organ offer.
After the patients have given written informed consent to participate in the follow-up they will be included in the study and followed until 5 years after randomization in the ConfIdeS study.
Most of the assessments in this study are already part of the follow up within SoC for these patients. During the local clinic routine follow-up visits at year 2, 3 and 5 after randomization in the ConfIdeS study, information about patient survival, wait-list status, graft survival, kidney function, and health related quality of life will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent obtained before any trial-related procedures.
- •Previous participation in the clinical trial ConfIdeS.
排除标准
- •1. Inability by the judgement of the investigator to participate in the trial for any reason.
研究组 & 干预措施
Imlifidase administered in the ConfIdeS study
干预措施: Imlifidase administered in the ConfIdeS study (Drug)
Best available treatment administered in the ConfIdeS study
干预措施: Best available treatment administered in the ConfIdeS study (Other)
结局指标
主要结局
Proportion of patients alive and free of dialysis at 3 years
时间窗: 3 years after randomization in the ConfIdeS study
次要结局
- Number of patients per wait-list category(3 and 5 years after randomization in the ConfIdeS study)
- Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years(3 and 5 years after randomization in the ConfIdeS study)
- Proportion of patients alive and free of dialysis at 5 years(5 years after randomization in the ConfIdeS study)
- Proportion of patients alive at 3 and 5 years(3 and 5 years after randomization in the ConfIdeS study)
- Graft failure-free survival rates at 3 and 5 years(3 and 5 years after randomization in the ConfIdeS study)
- Graft survival rates at 3 and 5 years(3 and 5 years after randomization in the ConfIdeS study)
- Proportion of patients with biopsy- and serology confirmed antibody-mediated rejection (AMR)(3 and 5 years after randomization in the ConfIdeS study)
- Proportion of patients with biopsy confirmed cell-mediated rejection(3 and 5 years after randomization in the ConfIdeS study)
- Treatment of graft rejection episodes(3 and 5 years after randomization in the ConfIdeS study)