Diabetic NephropathyPhase 2NCT07764991
Lactoferrin Supplementation in Diabetic Nephropathy
A Phase 2 study testing Lactoferrin and Antidiabetic in people with Diabetic Nephropathy, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Lactoferrin and Antidiabetic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo, 11566
Nihal Halawa, MSc in Clinical Pharmacy, 00201009716047, nihal.halawa3@pharma.asu.edu.eg
nihal.halawa3@pharma.asu.edu.eg
About this study
Official title: The Effect of Lactoferrin on the Clinical Outcome of Patients With Diabetic Nephropathy
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
- Being tested
- Lactoferrin, Antidiabetic, Placebo
- Keywords
- lactoferrin, diabetic nephropathy
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDietary supplement
Lactoferrin 250mg/day
AntidiabeticDrug
Antidiabetic (insulin+/oral hypoglycemics)
PlaceboOther
Placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin arm | Experimental | 30 patients will receive standard therapy + LF in an oral dose of 250 mg/day for 12 weeks Receives: Dietary Supplement: Lactoferrin; Drug: Antidiabetic |
| Placebo arm | Placebo comparator | 30 patients receiving standard therapy + placebo for 12 weeks. Receives: Drug: Antidiabetic; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary albumin/creatinine ratio
Measured: 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).
Measured: Baseline and after 12 weeks
Glycemic indices (fasting blood glucose and hemoglobin A1c).
Measured: Baseline and after 12 weeks
Lipid profile (low-density lipoprotein cholesterol, high- density lipoprotein cholesterol, total cholesterol and triglycerides).
Measured: Baseline and after 12 weeks
Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline and after 12 weeks
Osteopontin as a biomarker of oxidative stress
Measured: Baseline and after 12 weeks
Quality of life using the Kidney Disease Quality of Life Instrument (KDQOL -36™ Survey)
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Aug 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihal Mohamed Halawa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764991
- Sponsor's protocol ID
- RHDIRB2020110301 REC #458
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactoferrin on the Clinical Outcome of Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT07764991
- Acronym / sponsor ID
- RHDIRB2020110301 REC #458
- Conditions
- Diabetic Nephropathy
- Keywords
- lactoferrin, diabetic nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin arm | Experimental | Dietary Supplement: Lactoferrin, Drug: Antidiabetic30 patients will receive standard therapy + LF in an oral dose of 250 mg/day for 12 weeks |
| Placebo arm | Placebo comparator | Drug: Antidiabetic, Other: Placebo30 patients receiving standard therapy + placebo for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactoferrinLactoferrin 250mg/day | Dietary supplement | Lactoferrin arm |
| AntidiabeticAntidiabetic (insulin+/oral hypoglycemics) | Drug | Lactoferrin arm, Placebo arm |
| PlaceboPlacebo pills | Other | Placebo arm |
Primary outcome
Urinary albumin/creatinine ratio
Time frame: Baseline and after 12 weeks
6 secondary outcomes
Kidney function tests (serum creatinine, estimated glomerular filteration rate ( by ckd-epi equation) and blood urea nitrogen).
Time frame: Baseline and after 12 weeks
Glycemic indices (fasting blood glucose and hemoglobin A1c).
Time frame: Baseline and after 12 weeks
Lipid profile (low-density lipoprotein cholesterol, high- density lipoprotein cholesterol, total cholesterol and triglycerides).
Time frame: Baseline and after 12 weeks
Body mass index
Time frame: Baseline and after 12 weeks
Osteopontin as a biomarker of oxidative stress
Time frame: Baseline and after 12 weeks
Quality of life using the Kidney Disease Quality of Life Instrument (KDQOL -36™ Survey)
Time frame: Baseline and after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetic Nephropathy
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
Not yet recruitingObservational study
Impact of AI-Based Breath Ammonia Kidney Function Results on Clinical Pharmacist Medication Recommendations
Diabetes Mellitus, Type 2, Diabetic Nephropathies
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Not yet recruitingPhase 2
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Type 1 Diabetes Mellitus With Diabetic Nephropathy
Active, not recruitingObservational study
Wearable NH₃ Sensor for Remote Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease
Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactoferrin and Antidiabetic in people with Diabetic Nephropathy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nihal Halawa, MSc in Clinical Pharmacy (00201009716047, nihal.halawa3@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary albumin/creatinine ratio (time frame: Baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.