A Prospective, Post-authorisation Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation, Including a Non-comparative Concurrent Reference Cohort
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)
研究概览
简要总结
A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.
详细描述
This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were transplanted with a new kidney after treatment with imlifidase (trial drug) or standard of care medication. Imlifidase is a medicine used to prevent the body from rejecting a newly transplanted kidney and is used before transplantation in adults who have antibodies against the donor kidney and are considered 'highly sensitised' based on a positive crossmatch test.
The purpose of this follow-up trial is to fulfil requirements from the European Medicines Agency (EMA) to continue to evaluate efficacy (kidney function) and safety (side effects) over time, for the patients who were transplanted with a new kidney in the PAES trial. The patients will be followed for up to 5 years after transplantation in the PAES trial to collect valuable long-term data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent obtained before any trial-related procedures
- •Willingness and ability to comply with the protocol
- •Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES)
排除标准
- •Inability by the judgment of the investigator to participate in the trial for other reasons
研究组 & 干预措施
Non-Comparative Concurrent Reference Cohort
Best available treatment administered in the 20-HMedIdeS-19 (PAES) study
干预措施: Best available treatment administered in the 20-HMedIdeS-19 (PAES) study (Other)
Imlifidase
Imlifidase administered in the 20-HMedIdeS-19 (PAES) study
干预措施: Imlifidase administered in the 20-HMedIdeS-19 (PAES) study (Drug)
结局指标
主要结局
Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)
时间窗: 5-years after transplantation
Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft. The 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.
次要结局
- Graft failure-free survival (%) up to 2 and 3 years after transplantation(2 and 3-years after transplantation)
- Graft failure-free survival (%) up to 5 years after transplantation (non-comparative concurrent reference cohort only)(5-years after transplantation)
- Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) and serum/plasma creatinine levels(2, 3, and 5-years after transplantation)
- Patient survival (%) after transplantation(2, 3, and 5-years after transplantation)
- Graft survival (%) after transplantation(2, 3, and 5-years after transplantation)
- Human Leukocyte Antigen (HLA)/Donor Specific Antibodies (DSA) levels (imlifidase cohort only)(2, 3, and 5-years after transplantation)
- Anti-drug antibody (ADA) levels (imlifidase cohort only)(2, 3, and 5-years after transplantation)
- Proportion of patients (%) with biopsy- and serology (DSA)-confirmed Antibody Mediated Rejections (AMRs)(2, 3, and 5-years after transplantation)
- Proportion of patients (%) with biopsy confirmed Cell-Mediated Rejections (CMRs)(2, 3, and 5-years after transplantation)
- Treatment of graft rejections(2, 3, and 5-years after transplantation)
- Adverse events (AEs)/serious adverse events (SAEs) suspected to be related to imlifidase treatment (imlifidase cohort only)(2, 3, and 5-years after transplantation)
- Use of immunosuppressive medication(2, 3, and 5-years after transplantation)
- Comorbidities(2, 3, and 5-years after transplantation)
- Change in patient reported life participation(2, 3, and 5-years after transplantation)
- Treatment of graft rejection(2, 3, and 5-years after transplantation)