Lactoferrin Supplement in Diabetic Kidney Disease

Is this trial a fit for you?

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

What this trial studies

This Phase 2 interventional study investigates lactoferrin as a dietary supplement in adults with type 2 diabetes and chronic kidney disease (stages 3 or 4) who have elevated urine albumin levels. Participants will continue standard diabetes and kidney care while receiving lactoferrin or a placebo to see if the supplement reduces inflammation, oxidative stress, and urinary protein levels. The trial builds on preclinical data suggesting lactoferrin has antioxidant and anti-inflammatory effects that may protect kidney function. The study excludes individuals with recent trials, pregnancy, active cancer, or known lactoferrin intolerance. Outcomes focus on safety, kidney function, and changes in albuminuria over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participation in other interventional trials
* Current or previous treatment with LF supplements at least three months before inclusion.
* Kidney donor or recipient
* Pregnancy or breastfeeding
* Active malignancy
* Poor adherence potential (e.g. cognitive impairment, psychiatric instability)
* Known intolerance or allergy to lactoferrin

Where it's running

• Ain Shams University Hospitals
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Nihal Halawa, MSc in Clinical Pharmacy
• Email: nihal.halawa3@pharma.asu.edu.eg
• Phone: 00201009716047

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Umbilical Cord Mesenchymal Stem Cells for Diabetic Kidney Disease

  This study tests whether injecting human umbilical cord mesenchymal stem cells can help people with diabetic nephropathy by reducing kidney inflammation and damage.

  Recruiting Phase 1 Tongji Hospital · Wuhan · NCT07822152

• A system for preventing and controlling diabetic nephropathy

  This study is trying to create a system to better understand and manage diabetic nephropathy by collecting data on risk factors and symptoms from a large group of people with diabetes.

  Recruiting Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT06843304

• Using Raman Spectroscopy to Diagnose Kidney Diseases

  This study is testing a new way to diagnose kidney diseases by analyzing urine and blood samples from patients with specific kidney conditions to see if it can help identify the diseases more accurately.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT06760845

• Data repository for kidney diseases and related conditions

  This study is collecting health information and samples from people with different kidney diseases to see how various factors affect their condition and treatment.

  Recruiting The Rogosin Institute · New York, New York · NCT01802034

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.