A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Prokidney
- 入组人数
- 53
- 试验地点
- 5
- 主要终点
- Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.
研究概览
简要总结
The purpose of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT) / rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease (CKD).
详细描述
The objective of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT)/ rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD):
- Cohort 1: Two scheduled REACT/ rilparencel injections given 3 months (+60 days) with at least 18- month follow-up
- Cohort 2: One scheduled REACT/ rilparencel injection with a possible second REACT/ rilparencel injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT/ rilparencel injection).
Both cohorts will be followed for 18 months after the final REACT/ rilparencel injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.
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
- 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
- •Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
- •Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, controlled per institutional standard of care.
- •The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
- •The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
- •The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.
排除标准
- •The subject has a history of renal transplantation.
- •The subject 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.
- •Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.
- •The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for Chronic Kidney Disease-related anemia prior to randomization.
研究组 & 干预措施
2 Renal Autologous Cell Therapy (REACT)/ rilparencel injections
Cohort 1 subjects will receive 2 REACT/ rilparencel injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).
干预措施: Renal Autologous Cell Therapy (REACT) (Biological)
1 Renal Autologous Cell Therapy (REACT)/ rilparencel Injection
Cohort 2 subjects will receive 1 REACT / rilparencel injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT/ rilparencel injection into the contralateral kidney.
干预措施: Renal Autologous Cell Therapy (REACT) (Biological)
结局指标
主要结局
Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.
时间窗: Screening thru 18 months after the last injection of study drug
Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation
时间窗: Screening thru month 28
次要结局
未报告次要终点