A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Prokidney
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Primary Endpoints is as follows:
研究概览
简要总结
The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.
详细描述
A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.
- •The participant is male or female, 30 to 80 years of age on the date of informed consent.
- •The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.
- •The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.
排除标准
- •The participant has a history of renal transplantation.
- •The participant has received dialysis for more than 30 days.
- •The participant has received any other investigational products after completion of REACT injections within 3 months of screening.
- •The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.
- •The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.
研究组 & 干预措施
Renal Autologous Cell Therapy (REACT)
Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
干预措施: Renal Autologous Cell Therapy (REACT) (Biological)
结局指标
主要结局
Primary Endpoints is as follows:
时间窗: through 12 months after last supplemental injection
Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via: 1. Biopsy Related SAEs 2. Injection Procedure Related SAEs 3. Investigational Product Related SAEs 4. Treatment-Emergent SAEs.
次要结局
- First Secondary Endpoint(12 months after the last supplemental injection)
- Second Secondary Endpoint(12 months after the last supplemental injection)