Lactoferrin Supplementation in Diabetic Nephropathy

NCT07764991 | Recruiting Phase 2 DMC

• 1 other identifier: RHDIRB2020110301 REC #458
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Nephropathy

Keywords

lactoferrin; diabetic nephropathy

Outcome Measures

Primary Outcomes (1)

• Urinary albumin/creatinine ratio

  Baseline and after 12 weeks

Secondary Outcomes (6)

• Kidney function tests (serum creatinine, estimated glomerular filteration rate ( by ckd-epi equation) and blood urea nitrogen).

  Baseline and after 12 weeks

• Glycemic indices (fasting blood glucose and hemoglobin A1c).

  Baseline and after 12 weeks

• Lipid profile (low-density lipoprotein cholesterol, high- density lipoprotein cholesterol, total cholesterol and triglycerides).

  Baseline and after 12 weeks

• Body mass index

  Baseline and after 12 weeks

• Osteopontin as a biomarker of oxidative stress

  Baseline and after 12 weeks

Study Arms (2)

Lactoferrin arm

EXPERIMENTAL

30 patients will receive standard therapy + LF in an oral dose of 250 mg/day for 12 weeks

Dietary Supplement: Lactoferrin; Drug: Antidiabetic

Placebo arm

PLACEBO COMPARATOR

30 patients receiving standard therapy + placebo for 12 weeks.

Drug: Antidiabetic; Other: Placebo

Interventions

Lactoferrin DIETARY_SUPPLEMENT

Lactoferrin 250mg/day

Lactoferrin arm

Antidiabetic DRUG

Antidiabetic (insulin+/oral hypoglycemics)

Lactoferrin arm; Placebo arm

Placebo OTHER

Placebo pills

Placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Life expectancy \>12 months.

You may not qualify if:

• Participation in other interventional trials
• Kidney donor or recipient
• Pregnancy or breastfeeding
• Active malignancy
• Poor adherence potential (e.g. cognitive impairment, psychiatric instability)
• Known intolerance or allergy to lactoferrin

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Lactoferrin; Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Nihal Halawa, MSc in Clinical Pharmacy

CONTACT

00201009716047; nihal.halawa3@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of clinical pharmacy

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)