A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Prokidney
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Primary Endpoint: Long-term safety of REACT
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).
详细描述
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (RMCL-002, REGEN-003, REGEN-004) will be monitored for up to five years with alternating in clinic and phone visits.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol.
排除标准
- •The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.
研究组 & 干预措施
CKD patients previously treated with REACT
Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1).
干预措施: Renal Autologous Cell Therapy (REACT) (Biological)
结局指标
主要结局
Primary Endpoint: Long-term safety of REACT
时间窗: 60 months from completion of parent protocol EOS Visit
Evaluation of the long-term safety of REACT will be assessed via: 1. Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 2. Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 3. Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 4. Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
次要结局
- First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m²(60 months from completion of parent protocol EOS Visit)
- Second Secondary Endpoint: Time from first injection to chronic dialysis.(60 months from completion of parent protocol EOS Visit)
- Third Secondary Endpoint: Time from first injection to renal transplant.(60 months from completion of parent protocol EOS Visit)