A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies REGEN-006, REGEN-007, and REGEN-015 (REGEN-008S2)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Prokidney
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.
详细描述
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) 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 REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol.
- •The participant is willing and able to cooperate with all aspects of the protocol.
- •The participant is willing and able to provide signed informed consent.
排除标准
- •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 REGEN-007, REGEN-006, REGEN-015 (REGEN-008S2).
干预措施: Renal Autologous Cell Therapy (REACT) (Biological)
结局指标
主要结局
Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.
时间窗: 60 months from completion of parent protocol EOS Visit
Evaluation of the long-term safety of REACT will be assessed via: * Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * 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
- Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.(60 months from completion of parent protocol EOS Visit)
- Time from first injection to chronic dialysis.(60 months from completion of parent protocol EOS Visit)
- Time from first injection to a cardiovascular death.(60 months from completion of parent protocol EOS Visit)
- Time from first injection to renal transplant(60 months from completion of parent protocol EOS Visit)
- Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD) at Months 12, 24, 36, 48, and 60.(60 months from completion of parent protocol EOS Visit)
- Time from first injection to a renal death.(60 months from completion of parent protocol EOS Visit)
- Percent of participants who have the same or reduced 2-year risk of end stage renal disease at Months 12, 24, 36, 48, and 60.(60 months from completion of parent protocol EOS Visit)