NCT07764991RecruitingPhase 2
Lactoferrin Supplementation in Diabetic Nephropathy
The Effect of Lactoferrin on the Clinical Outcome of Patients With Diabetic Nephropathy
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
Multiple pathways and mediators, including oxidative stress, inflammation, and the over-activity of the renin-angiotensin-aldosterone system are involved in the development of albuminuria and progression of diabetic nephropathy (DN), of which oxidative stress is the most prominent. Previous research has shown that lactoferrin (LF) has multi-pharmacological properties, including antioxidant, anti-inflammatory, antiviral, anticancer, antibacterial, antifibrotic and immunogenic properties . Lactoferrin was reported to be a useful nutritional supplement to support immunity and antioxidant status and suppress systemic inflammatory and oxidative stress biomarkers ( ↓ TNF-α, ↓ IL-6, ↓ IFN-γ, ↓ IL-1β, ↑ IL-10) in previous studies. Lactoferrin, in vitro, has been reported to reduce oxidative stress, inflammation, apoptosis and fibrosis in acute and chronic kidney disease. Moreover, different rat models with kidney injury have proven the nephroprotective effect of LF through decreasing the levels of urinary albumin to creatinine ratio, serum creatinine, serum urea, and blood urea nitrogen (BUN) and also through reducing the expression of kidney damage markers; osteopontin, renin and IL-6. Furthermore, LF improved glycemic control and lipid markers through significant improvement of HbA1c, FBG, insulin resistance, body mass index and lipid markers. Hence, this study aims to evaluate the effect of LF on the clinical outcomes of type 2 diabetic patients with DN.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Aug 2026
- Start date
- 1 Aug 2025
- Primary completion date
- Feb 2027
- Lead sponsor
- Ain Shams University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07764991
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Aug 2025 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous treatment with LF supplements at least three months before inclusion.
Other illness
- Active malignancy
- Poor adherence potential (e.g. cognitive impairment, psychiatric instability)
- Known intolerance or allergy to lactoferrin
Other
- Participation in other interventional trials
- Kidney donor or recipient
- Pregnancy or breastfeeding
Who the study is looking for
- Age ≥ 18 years
- Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min/1.73m2) or stage 4 (eGFR 15-29 ml/min/1.73m2)
- Urinary albumin/Creatinine ratio (UACR): moderately and severely increased albuminuria (\> 30 mg/g)
- Stable standard therapy for at least three months prior to inclusion in the study.
- Life expectancy \>12 months.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ain Shams University Hospitals Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.