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

NCT07187713 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-09-23

No results posted yet for this study

Summary

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.

Conditions

  • Hypertensive Nephropathy
  • Auto Immune Disorders
  • Chronic Kidney Disease
  • Chronc Kidney Disease Stage 5
  • Chronic Kidney Disease (Stage 3-4)
  • Chronic Kidney Disease (Stages 4 and 5)
  • Microalbuminuria
  • Diabetic Nephropathies

Interventions

DRUG

ACE Reno

1 ml sublingual 4 times daily for 12 weeks

Sponsors & Collaborators

  • Ace Cells Lab Limited

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Mohammed Yasser Sayyed Saif, PhD · Beni Suef Univeristy

  • Dr. Alaa Abdelkarim M Fouad, MRCPUK SEC · British Centre for Regenerative medicine BCRMED

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-20
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07187713 on ClinicalTrials.gov