NCT07187713 ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases
| NCT ID | NCT07187713 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ace Cells Lab Limited |
| Condition | Hypertensive Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-20 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-09-20 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Recent kidney transplant (\<12 months). Uncontrolled acute infection or unstable autoimmune disease. Pregnancy or lactation. Known hypersensitivity to study components.
Contact & Investigator
Prof. Dr. Mohammed Yasser Sayyed Saif, PhD
PRINCIPAL INVESTIGATOR
Beni Suef Univeristy
Frequently Asked Questions
Who can join the NCT07187713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hypertensive Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07187713 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07187713 currently recruiting?
Yes, NCT07187713 is actively recruiting participants. Contact the research team at dralaa@ace-cells.co.uk for enrollment information.
Where is the NCT07187713 trial being conducted?
This trial is being conducted at Giza, Egypt.
Who is sponsoring the NCT07187713 clinical trial?
NCT07187713 is sponsored by Ace Cells Lab Limited. The principal investigator is Prof. Dr. Mohammed Yasser Sayyed Saif, PhD at Beni Suef Univeristy. The trial plans to enroll 300 participants.