A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Prokidney
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Primary Composite Endpoint
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
详细描述
Randomized multi-center, blinded intervention, two cohort , study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will undergo sham procedures and be followed for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 is male or female, 30 to 80 years of age on the date of informed consent.
- •The participant has a clinical diagnosis of T2DM in their health record.
- •The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
- •The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
- •The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 44 mL/min/1.73m², not requiring renal dialysis.
- •The participant has an urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.
排除标准
- •The participant has a history of type 1 diabetes mellitus.
- •The participant has a history of renal transplantation.
- •The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated.
- •The participant has hemoglobin level less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.
研究组 & 干预措施
Sham Procedure
Participants randomized to the Sham Comparator arm will have 2 sham procedures
干预措施: Sham Comparator (Procedure)
Experimental (REACT injections)
Participants randomized to the experimental arm will receive 2 injections of REACT.
干预措施: Renal Autologous Cell Therapy (REACT) (Biological)
结局指标
主要结局
Primary Composite Endpoint
时间窗: up to 60 Months post last injection of the investigational product or the last simulated injection.
The time from first injection to the earliest of: * At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or * eGFR \<15 mL/min/1.73m² using the 2009 serum creatinine equation, sustained for 30 days and/or chronic dialysis , and/or renal transplant or * Renal or cardiovascular death
次要结局
- First Secondary Endpoint: Time to progression of Chronic Kidney Disease(up to 60 Months post last injection of the investigational product or the last simulated injection)
- Second Secondary Endpoint: Time to End Stage Renal Disease(up to 60 Months post last injection of the investigational product or the last simulated injection)