A Phase 2 interventional study of Lactoferrin and Antidiabetic in Diabetic Nephropathy, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 24 studies in Diabetic Nephropathies with a site in Egypt — 6 open to participants now, 6 under way, 1 of them phase 3. Diabetic Nephropathies · Egypt.
Among the 24 studies in Diabetic Nephropathies with a site in Egypt, this one is the 8th largest by planned enrollment of the 17 interventional ones that give a count, is one of 5 that started in 2025, is one of 4 in phase 2, and was the 22nd registered.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
Browse Diabetic Nephropathies studies →6 of the 24 studies in Diabetic Nephropathies with a site in Egypt are open now. Recruiting first, the newest first:
Ace Cells Lab Limited · Sites in Egypt
Ages 18–80
Ain Shams University · Sites in Egypt
Ages 18+
Assiut University · Sites in Egypt
Ages 18+
Assiut University · Sites in Egypt
Ages 10–17
Assiut University · Sites in Egypt
Ages 18–80
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 50 Diabetic Nephropathies studies recruiting now, 23 (46%) set no upper age limit and 16 (32%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 7 · Phase 4 2
First in 2018; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Median enrollment 60 across the 17 interventional studies, 100 across the 7 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 24 have an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 6 studies filed under Diabetic Nephropathies — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetic Nephropathies with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07764991Ain Shams UniversityLactoferrin Supplementation in Diabetic Nephropathy | 2027-02 |
Add it to your calendar (.ics) → With an account.
Among the 24 studies in Diabetic Nephropathies with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 patients will receive standard therapy + LF in an oral dose of 250 mg/day for 12 weeks
Dietary Supplement: Lactoferrin · Drug: Antidiabetic
30 patients receiving standard therapy + placebo for 12 weeks.
Drug: Antidiabetic · Other: Placebo
Lactoferrin 250mg/day
Antidiabetic (insulin+/oral hypoglycemics)
Placebo pills
Urinary albumin/creatinine ratio
Time frame: Baseline and after 12 weeks
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
Weight and height will be combined to report BMI in kg/m\^2
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
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Feb 2027, 18 months after the start.
Of 52 phase 2 interventional studies under Diabetic Nephropathies, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Lactoferrin