Study of ACE Reno Sublingual Solution for Adults With Nephropathy or Chronic Kidney Disease Evaluating Effects on Kidney Function, Proteinuria, and Safety Over 12 Weeks

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy caused by various conditions like diabetes, hypertension, autoimmune diseases, and chronic kidney disease CKD stages 1 to 5. The trial aims to determine if 12 weeks of ACE Reno treatment can reduce albuminuria or proteinuria and stabilize kidney function in these patients. Nephropathy is a significant global health issue affecting millions and leading to high socioeconomic costs worldwide. Participants will receive ACE Reno as a sublingual solution at a dose of 1 mL four times daily for 12 weeks. The solution contains peptide components designed to target pathways involved in kidney damage, including antifibrotic and vasodilatory mechanisms. This is an open-label, single-arm study with assessments at screening, baseline, weeks 4, 8, and 12, followed by a safety follow-up call at week 16. During the study, participants will undergo clinical evaluations including blood pressure, vital signs, weight, and laboratory tests such as creatinine, estimated glomerular filtration rate eGFR, electrolytes, liver panel, complete blood count, and urine albumin-to-creatinine ratio ACR. Patient-reported outcomes on fatigue and quality of life will also be collected. The primary outcome is the change in urinary ACR after 12 weeks. Safety and tolerability will be monitored throughout treatment and during the 4-week post-treatment follow-up period.

ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases