CKD - Chronic Kidney DiseasePhase 4NCT05714176
Comparative Study Between Oral Liposomal Iron,Iron Supported Lactoferrin and IV Iron Dextran in CKD Children
A Phase 4 study testing Ferric Pyrophosphate Liposomal, Lactoferrin and Iron Dextran Injection in people with CKD - Chronic Kidney Disease, run by Menoufia University.
Trial summary
This is a randomized, parallel study that will be conducted on pediatric patients with CKD. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- CKD - Chronic Kidney Disease
- What is being tested?
- Ferric Pyrophosphate Liposomal, Lactoferrin and Iron Dextran Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Dec 2024
- 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A) Pediatrics ≤18 year old male and female patients. B) Pediatrics with CKD stages 3-5.
Who cannot join
- A) CKD patients' ≥18 year old. B) Active bleeding C) Malignancy D) Anemia due to any disease other than CKD E) Blood Transfusions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Clinical Study to Evaluate the Efficacy and Safety of Oral Liposomal Iron, Oral Iron Supported Lactoferrin and IV Iron Dextran in Children With Chronic Kidney Disease
This is a randomized, parallel study that will be conducted on pediatric patients with CKD.
Read the detailed description
The study will be conducted on 90 pediatric patients with CKD who will be divided into 3 groups: Group l: 30 pediatric patients who will receive oral liposomal iron 30 mg/day for 12 weeks. Group 2: 30 pediatric patients who will receive oral iron supported iron 1 mg+ lactoferrin 100 mg/day for 12 weeks. Group 3: 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.
- Conditions
- CKD - Chronic Kidney Disease
- Being tested
- Ferric Pyrophosphate Liposomal, Lactoferrin, Iron Dextran Injection
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Pyrophosphate LiposomalDrug
Also called Novoferr
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
LactoferrinDrug
Also called Provan
30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.
Iron Dextran InjectionDrug
30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal iron | Experimental | 30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks. Receives: Drug: Ferric Pyrophosphate Liposomal |
| Iron supported Lactoferrin | Experimental | 30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks. Receives: Drug: Lactoferrin |
| Iv iron dextran | Experimental | 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks. Receives: Drug: Iron Dextran Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin measure
Measure oxygen in blood by measuring hemoglobin by coloremetric assay
Measured: 3 months
Secondary outcomes (1)
Biomarkers measure
changes in serum levels of biological biomarkers( measure IL-6, hepcidin and GDF-15 by ELISA assay).
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 posted6 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CKD - Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Mai Salah El-Din, Menoufia University
- Investigators
- Sahar K Hagazy, PhD, Study chair, Tanta UniversityMohamed SH Al-Haron, Study chair, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714176
- Sponsor's protocol ID
- Iron in CKD children
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amanullah F, Malik AA, Zaidi Z. Chronic kidney disease causes and outcomes in children: Perspective from a LMIC setting. PLoS One. 2022 Jun 8;17(6):e0269632. doi: 10.1371/journal.pone.0269632. eCollection 2022.
PubMed 35675292Ammirati AL. Chronic Kidney Disease. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s03-s09. doi: 10.1590/1806-9282.66.S1.3.
PubMed 31939529Ueda N, Takasawa K. Role of Hepcidin-25 in Chronic Kidney Disease: Anemia and Beyond. Curr Med Chem. 2017;24(14):1417-1452. doi: 10.2174/0929867324666170316120538.
PubMed 28302014Moscheo C, Licciardello M, Samperi P, La Spina M, Di Cataldo A, Russo G. New Insights into Iron Deficiency Anemia in Children: A Practical Review. Metabolites. 2022 Mar 25;12(4):289. doi: 10.3390/metabo12040289.
PubMed 35448476Wojtaszek E, Glogowski T, Malyszko J. Iron and Chronic Kidney Disease: Still a Challenge. Front Med (Lausanne). 2020 Dec 18;7:565135. doi: 10.3389/fmed.2020.565135. eCollection 2020.
PubMed 33392212Hegazy SK, Koura MSE, Elharoun MS. Oral lactoferrin as a treatment of pediatrics' anemia resulted from chronic kidney diseases: a randomized controlled trial. Sci Rep. 2025 Feb 5;15(1):4380. doi: 10.1038/s41598-025-88506-2.
PubMed 39910177
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study to Evaluate the Efficacy and Safety of Oral Liposomal Iron, Oral Iron Supported Lactoferrin and IV Iron Dextran in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05714176
- Acronym / sponsor ID
- Iron in CKD children
- Conditions
- CKD - Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 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.
This is a randomized, parallel study that will be conducted on pediatric patients with CKD.
Detailed description
The study will be conducted on 90 pediatric patients with CKD who will be divided into 3 groups: Group l: 30 pediatric patients who will receive oral liposomal iron 30 mg/day for 12 weeks. Group 2: 30 pediatric patients who will receive oral iron supported iron 1 mg+ lactoferrin 100 mg/day for 12 weeks. Group 3: 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liposomal iron | Experimental | Drug: Ferric Pyrophosphate Liposomal30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks. |
| Iron supported Lactoferrin | Experimental | Drug: Lactoferrin30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks. |
| Iv iron dextran | Experimental | Drug: Iron Dextran Injection30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- A) Pediatrics ≤18 year old male and female patients. B) Pediatrics with CKD stages 3-5.
Key exclusion criteria (1 listed)
- A) CKD patients' ≥18 year old. B) Active bleeding C) Malignancy D) Anemia due to any disease other than CKD E) Blood Transfusions
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 |
|---|---|---|
| Ferric Pyrophosphate LiposomalAlso: Novoferr30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks. | Drug | Liposomal iron |
| LactoferrinAlso: Provan30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks. | Drug | Iron supported Lactoferrin |
| Iron Dextran Injection30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks. | Drug | Iv iron dextran |
Primary outcome
Hemoglobin measure
Time frame: 3 months
Measure oxygen in blood by measuring hemoglobin by coloremetric assay
1 secondary outcome
Biomarkers measure
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 6 Feb 2023.
- Background: PubMed 35675292Amanullah F, Malik AA, Zaidi Z. Chronic kidney disease causes and outcomes in children: Perspective from a LMIC setting. PLoS One. 2022 Jun 8;17(6):e0269632. doi: 10.1371/journal.pone.0269632. eCollection 2022.
- Background: PubMed 31939529Ammirati AL. Chronic Kidney Disease. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s03-s09. doi: 10.1590/1806-9282.66.S1.3.
- Background: PubMed 28302014Ueda N, Takasawa K. Role of Hepcidin-25 in Chronic Kidney Disease: Anemia and Beyond. Curr Med Chem. 2017;24(14):1417-1452. doi: 10.2174/0929867324666170316120538.
- Background: PubMed 35448476Moscheo C, Licciardello M, Samperi P, La Spina M, Di Cataldo A, Russo G. New Insights into Iron Deficiency Anemia in Children: A Practical Review. Metabolites. 2022 Mar 25;12(4):289. doi: 10.3390/metabo12040289.
- Background: PubMed 33392212Wojtaszek E, Glogowski T, Malyszko J. Iron and Chronic Kidney Disease: Still a Challenge. Front Med (Lausanne). 2020 Dec 18;7:565135. doi: 10.3389/fmed.2020.565135. eCollection 2020.
- Derived from this study: PubMed 39910177Hegazy SK, Koura MSE, Elharoun MS. Oral lactoferrin as a treatment of pediatrics' anemia resulted from chronic kidney diseases: a randomized controlled trial. Sci Rep. 2025 Feb 5;15(1):4380. doi: 10.1038/s41598-025-88506-2.
- 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.
Sahar K Hagazy, PhD study chair
Tanta University
Mohamed SH Al-Haron study chair
Menoufia University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Pyrophosphate Liposomal, Lactoferrin and Iron Dextran Injection in people with CKD - Chronic Kidney Disease, run by Menoufia University.
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 1 inclusion and 1 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mai SE Koura, MSc (201274117967, dr.pharmasist@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin measure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05714176, which also lists 6 linked publications.
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 6 Feb 2023.