Actively Recruiting
ACE Reno Effect on Micro-albuminuria, Proteinuria, and CKD Due to Diabetes, Autoimmune, or Other Causes
Led by Ace Cells Lab Limited · Updated on 2025-09-23
300
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 80 years old
- Diagnosed with nephropathy of any degree including microalbuminuria, overt proteinuria, CKD stages 1 to 5 not on dialysis, or post-transplant with proteinuria
- Stable background therapy with ACE inhibitors, ARBs, SGLT2 inhibitors, or MRAs allowed
You will not qualify if you...
- Kidney transplant within the past 12 months
- Uncontrolled acute infection or unstable autoimmune disease
- Pregnancy or lactation
- Known hypersensitivity to study components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 12 weeks
Participants receive ACE Reno sublingual solution four times daily for 12 weeks to evaluate its effect on kidney function and protein levels.
Baseline visit (Day 0) and weekly visits at Week 4, Week 8, and Week 12
Duration - 4 weeks
Participants are followed for 4 weeks after treatment to monitor safety and any adverse events.
1 safety follow-up call at Week 16
Trial Site Locations
Total: 1 location
1
British Centre For Regenerative medicine BCRMED Global
Giza, GZ, Egypt, 12311
Actively Recruiting
Research Team
D
Dr. Alaa Abdelkarim M Fouad, MRCPUK SEC
D
Dr. Shireen S Amer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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