ACE Reno, Effect of Pico Cell Matrix on Patients With Micro-albuminuria, Proteinuria or CKD (of Any Degree) Due to Diabetes Mellitus, Autoimmune, Miscellaneous Aetiology
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Urinary Albumin-to-Creatinine Ratio (ACR)
研究概览
简要总结
This study investigates the safety and efficacy of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy of various etiologies and stages. The trial evaluates whether 12 weeks of ACE Reno (1 mL sublingually four times daily) reduces albuminuria/proteinuria and stabilizes kidney function in participants with nephropathy due to diabetes, hypertension, autoimmune disease, reflux/UTI, chronic glomerulonephritis, unknown etiology, pre-dialysis CKD, or post-transplant proteinuria.
Nephropathy remains a global health burden, with ~9-10% of the population affected by chronic kidney disease (CKD), equating to >750 million individuals worldwide. The socioeconomic costs are substantial: in England CKD costs ~£7 billion annually, projected to rise to ~£14 billion by 2033; in Malaysia, prevalence rose from 9% to 15.5% within 7 years; in Egypt, CKD imposes heavy familial and financial burdens, especially for pediatric patients; in Turkey, CKD is among the top causes of disability, linked to the rising tide of diabetes, obesity, and hypertension.
ACE Reno is designed to address multiple drivers of CKD progression - glomerulosclerosis, fibrosis, endothelial dysfunction, and maladaptive RAAS/aldosterone signaling - through its peptide components that mimic antifibrotic (BMP-7, HGF, Klotho-like) and vasodilatory/cGMP-mediated (natriuretic peptide-like) pathways.
详细描述
Study Objectives
Primary Objective:
To evaluate the effect of ACE Reno on urinary albumin-to-creatinine ratio (ACR) after 12 weeks of treatment in patients with nephropathy of diverse etiologies.
Secondary Objectives:
To assess the effect of ACE Reno on estimated glomerular filtration rate (eGFR) slope.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with nephropathy of any degree (microalbuminuria, overt proteinuria, CKD stages 1-5 not on dialysis, or post-transplant with proteinuria). Stable background therapy with ACEi/ARB, SGLT2i, or MRA allowed.
排除标准
- •Recent kidney transplant (<12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components.
研究组 & 干预措施
1 ml sublingual 4 times daily for 12 weeks
Participants will receive ACE Reno, a standardized oral transmucosal solution containing low-molecular-weight bioactive peptides and amino acids.
The formulation is designed to engage antifibrotic (BMP-7-like, HGF-like, Klotho-like) and vasodilatory/natriuretic peptide-like pathways relevant to glomerular and tubulointerstitial function.
No genetic material is present; formulation is peptide-based only.
干预措施: ACE Reno (Drug)
结局指标
主要结局
Change in Urinary Albumin-to-Creatinine Ratio (ACR)
时间窗: 12 weeks
Percent change in log-transformed urinary ACR measured from first-morning urine samples. The primary analysis compares baseline to Week 12 values
次要结局
- Change in Estimated Glomerular Filtration Rate (eGFR) slope(Baseline, Week 4, Week 8, Week 12)
- Change in 24-hour Proteinuria(Baseline to Week 12 (subset of participants with baseline nephrotic-range proteinuria))
- Change in Blood Pressure(Baseline, Week 4, Week 8, Week 12)
- Safety and Tolerability(Throughout treatment and up to Week 16 follow-up)