Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 80

ACE Reno Pico Cell Matrix for reducing proteinuria and supporting kidney function

Official title: 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

Run by Ace Cells Lab Limited · NCT07187713 · Data updated 2026-11-12

This trial will test whether taking ACE Reno, a sublingual peptide solution four times daily for 12 weeks, can lower urine protein and help stabilize kidney function in adults with nephropathy or chronic kidney disease.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment300 (estimated)
SponsorAce Cells Lab Limited
Industry-sponsored
Locations1 site (Giza, GZ)
StatusRecruiting
StartedSeptember 20, 2025
Main results expectedAugust 31, 2026
Study endsDecember 31, 2026
Registry record updatedSeptember 23, 2025
Trial IDNCT07187713 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with nephropathy or chronic kidney disease stages 1–5 not on dialysis, or post-transplant patients with proteinuria, who are willing to take a sublingual medication and attend scheduled visits are ideal candidates.

Probably not a fit

People on maintenance dialysis, those with a kidney transplant within the past 12 months, active uncontrolled infections or unstable autoimmune disease, pregnant or breastfeeding persons, or anyone with known hypersensitivity to the product are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm study giving ACE Reno (1 mL sublingually four times daily) for 12 weeks with a 4-week safety follow-up. The main measure is change in urinary albumin-to-creatinine ratio (ACR) at 12 weeks, with secondary measures including eGFR slope, proteinuria, blood pressure, and patient-reported outcomes. The trial enrolls adults with nephropathy across a range of causes and CKD stages (including post-transplant proteinuria) while allowing stable background therapies such as ACEi/ARB and SGLT2i. Exploratory biomarker analyses (e.g., TGF-β, NGAL, KIM-1, cGMP) and durability of response up to 6 months in responders will also be collected.

Why it matters

Potential benefit: If successful, ACE Reno could reduce albuminuria and slow kidney function decline, potentially delaying progression to advanced CKD or dialysis.

How similar studies have gone: This peptide-based, multi-domain sublingual approach is largely novel in clinical practice; there is some preclinical and early-phase supportive data for anti-fibrotic peptides but limited clinical evidence to date.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • British Centre For Regenerative medicine BCRMED Global
    Giza, Gz, Egypt
    Recruiting

Study contacts

  • Principal investigator: Prof. Dr. Mohammed Yasser Sayyed Saif, PhD — Beni Suef Univeristy
  • Study coordinator: Dr. Alaa Abdelkarim M Fouad, MRCPUK SEC
  • Email: dralaa@ace-cells.co.uk
  • Phone: +447473922553

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.