NCT03611621已完成不适用
A Prospective Observational, Long Term Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.
研究概览
简要总结
The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome for these subjects. Data of parameters such as patient and graft survival, comorbidity, treatment of graft rejection episodes and quality of life as well as anti-drug antibody levels will be collected.
This prospective, observational follow up study of subjects who have received imlifidase prior to kidney transplantation will provide important data to future prescribers and patients of the potential long-term benefits of imlifidase mediated transplantation.
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
- •Signed Informed Consent obtained before any study-related procedures
- •Previous dosing with imlifidase followed by kidney transplantation and participation in one of the following clinical studies: 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 or 15-HMedIdeS-06
排除标准
- •Individuals deemed unable to comply with the protocol
- •Inability by the judgment of the investigator to participate in the study for other reasons
结局指标
主要结局
Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.
时间窗: 5 years after first dose of imlifidase (in the feeder study)
The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss.
次要结局
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival.(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)).(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine).(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria).(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes.(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes.(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities.(5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5)
- Assessment of Safety Laboratory Testing in Terms of Hematology (Hb)(5 years after first dose of imlifidase (in the feeder study))
- Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)(5 years after first dose of imlifidase (in the feeder study))
- Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes)(5 years after first dose of imlifidase (in the feeder study))
- Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG)(5 years after first dose of imlifidase (in the feeder study))
- Assessment of Donor Specific Antibodies (DSA)(5 years after first dose of imlifidase (in the feeder study))
- Assessment of the Presence of BK Virus(5 years after first dose of imlifidase (in the feeder study))
- Assessment of the Immunogenicity of Imlifidase(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L).(5 years after first dose of imlifidase (in the feeder study))
- Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).(5 years after first dose of imlifidase (in the feeder study))
研究者
研究点 (6)
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