Anemia of Chronic Kidney DiseasePhase 4NCT05900635
Effect of Adding Lactoferrin on Oral Iron on Anemia in Chronic Kidney Disease Patients
A Phase 4 study testing Lactoferrin and Ferrous Glycine Sulfate in people with Anemia of Chronic Kidney Disease, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effects of adding lactoferrin to the every-other-day oral iron supplementation in iron deficiency anemia and chronic kidney disease patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of Chronic Kidney Disease
- What is being tested?
- Lactoferrin and Ferrous Glycine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females aged ≥ 18 years old
- Patients with eGFR ≥30 and ≤60 mL/min/1.73m2.
- Absolute iron deficiency anemia (Hgb <10g/dL, serum ferritin <300ng/ml and Transferrin Saturation < 30% )
Who cannot join
- Patients on intermittent hemodialysis (IHD)
- Patients with any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia)
- Patients who received EPO 4 weeks ago
- Patients who received IV Iron 8 weeks ago
- Patients who received blood Transfusion 8 weeks ago
- Current history of GI bleeding
Show all 9Show fewer
- Malignancy history
- Pregnancy or lactation in female participants
- Patients non-adherent to at least 80% of the regimen
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kidney and Urology Center
Alexandria, 21548
Ahmed F El Koraie, PhD, 01000304563, drahmed@hotmail.com
Engy m Emam, PharmD, 01223534690, engyemam2005@gmail.com
About this study
Official title: Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
The aim of this study is to evaluate the effects of adding lactoferrin to the every-other-day oral iron supplementation in iron deficiency anemia and chronic kidney disease patients.
Read the detailed description
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Sixty chronic kidney disease patients with iron defficiency anemia,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH). The 60 participants will be randomly assigned into 2 arms. Control arm (n=30): will be treated with oral ferrous glycine sulfate (100mg) every other day for 3 months Intervention arm (n=40): will be treated with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months.
- All patients will be subjected directly at time of enrollment to the following; Complete history taking and demographic data (age, sex, …)
- Blood samples will be drawn to measure the initial values of hemoglobin, hematocrit, serum iron, TIBC, Serum Transferrin Saturation (TSAT), and Hepcidin as primary outcome.
- All patients will be followed up and treated during the study time. All relevant routine investigations and medications will be recorded.
- At each visit, the subjects will be questioned about study compliance (diet and medications), concomitant medications, and adverse events.
- The results obtained from the work will be tabulated and statistically analyzed using the appropriate statistical methods.
- The findings will be discussed in view of the achievement of the aim, their significance and their comparison with other available works and information.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- Lactoferrin, Ferrous Glycine Sulfate
- Keywords
- Lactoferrin, Anemia, Chronic Kidney Disease, Oral iron
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDrug
Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
Ferrous Glycine SulfateDrug
Effect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Patients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months Receives: Drug: Ferrous Glycine Sulfate |
| Intervention | Active comparator | Patients in this group will initiate treatment with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months Receives: Drug: Lactoferrin; Drug: Ferrous Glycine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in the level of Hemoglobin measured in gm/dl
Measured: 3 months
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in the level of serum Iron measured in ug/mL
Measured: 3 months
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in total iron binding capacity (TIBC) measured in ug/mL
Measured: 3 months
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in serum transferrin saturation (TSAT) measured in %
Measured: 3 months
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Mean change in serum hepcidin measured in ng/ml
Measured: 3 months
Secondary outcomes (1)
Evaluation of tolerability and gastrointestinal adverse events
The subjects will be contacted to be questioned about medications adherence and adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Oct 2022
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open-labeled, parallel, randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed F Elkoraie, Prof, Principal investigator, Alexandria UniversityMagda A Elmassik, Prof, Principal investigator, Alexandria UniversityNoha A Hamdy, PhD, Principal investigator, Alexandria UniversityEngy M Emam, PharmD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900635
- Sponsor's protocol ID
- 0107174
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT05900635
- Acronym / sponsor ID
- 0107174
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- Lactoferrin, Anemia, Chronic Kidney Disease, Oral iron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 12 Jun 2023 (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.
The aim of this study is to evaluate the effects of adding lactoferrin to the every-other-day oral iron supplementation in iron deficiency anemia and chronic kidney disease patients.
Detailed description
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Sixty chronic kidney disease patients with iron defficiency anemia,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH). The 60 participants will be randomly assigned into 2 arms. Control arm (n=30): will be treated with oral ferrous glycine sulfate (100mg) every other day for 3 months Intervention arm (n=40): will be treated with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months.
- All patients will be subjected directly at time of enrollment to the following; Complete history taking and demographic data (age, sex, …)
- Blood samples will be drawn to measure the initial values of hemoglobin, hematocrit, serum iron, TIBC, Serum Transferrin Saturation (TSAT), and Hepcidin as primary outcome.
- All patients will be followed up and treated during the study time. All relevant routine investigations and medications will be recorded.
- At each visit, the subjects will be questioned about study compliance (diet and medications), concomitant medications, and adverse events.
- The results obtained from the work will be tabulated and statistically analyzed using the appropriate statistical methods.
- The findings will be discussed in view of the achievement of the aim, their significance and their comparison with other available works and information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-labeled, parallel, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: Ferrous Glycine SulfatePatients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months |
| Intervention | Active comparator | Drug: Lactoferrin, Drug: Ferrous Glycine SulfatePatients in this group will initiate treatment with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females aged ≥ 18 years old
- Patients with eGFR ≥30 and ≤60 mL/min/1.73m2.
- Absolute iron deficiency anemia (Hgb <10g/dL, serum ferritin <300ng/ml and Transferrin Saturation < 30% )
Key exclusion criteria (9 listed)
- Patients on intermittent hemodialysis (IHD)
- Patients with any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia)
- Patients who received EPO 4 weeks ago
- Patients who received IV Iron 8 weeks ago
- Patients who received blood Transfusion 8 weeks ago
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 |
|---|---|---|
| LactoferrinEffect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients | Drug | Intervention |
| Ferrous Glycine SulfateEffect of adding Lactoferrin to Oral Iron Supplementation for the treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients | Drug | Control, Intervention |
Primary outcome
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Time frame: 3 months
Mean change in the level of Hemoglobin measured in gm/dl
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Time frame: 3 months
Mean change in the level of serum Iron measured in ug/mL
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Time frame: 3 months
Mean change in total iron binding capacity (TIBC) measured in ug/mL
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Time frame: 3 months
Mean change in serum transferrin saturation (TSAT) measured in %
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
Time frame: 3 months
Mean change in serum hepcidin measured in ng/ml
1 secondary outcome
Evaluation of tolerability and gastrointestinal adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ahmed F Elkoraie, Prof principal investigator
Alexandria University
Magda A Elmassik, Prof principal investigator
Alexandria University
Noha A Hamdy, PhD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactoferrin and Ferrous Glycine Sulfate in people with Anemia of Chronic Kidney Disease, run by Alexandria 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Engy M Emam, Pharm D (01223534690, engyemam2005@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD (time frame: 3 months). The study lists 5 primary outcomes in all. 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 12 Jun 2023.