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.
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.
Recent kidney transplant (<12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components.
Single group
ACE Reno
Drug1 ml sublingual 4 times daily for 12 weeks
Change in Urinary Albumin-to-Creatinine Ratio (ACR)
Percent change in log-transformed urinary ACR measured from first-morning urine samples. The primary analysis compares baseline to Week 12 values
Change in Estimated Glomerular Filtration Rate (eGFR) slope
eGFR calculated from serum creatinine using CKD-EPI; slope analyzed via linear mixed model.
Change in 24-hour Proteinuria
Absolute and percent change in 24-hour urinary protein excretion.
Change in Blood Pressure
tp adjust BP : systolic \<=140 Diastolic \>100 up to 60 mmHg
Safety and Tolerability
measure 'Full blood count before and after 16 weeks
Hospitalization Events
Number of hospitalizations related to renal or cardiovascular complications.
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