NCT05714176

Brief Summary

This is a randomized, parallel study that will be conducted on pediatric patients with CKD.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 15, 2023

Last Update Submit

January 26, 2023

Conditions

CKD - Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin measure

    Measure oxygen in blood by measuring hemoglobin by coloremetric assay

    3 months

Secondary Outcomes (1)

  • Biomarkers measure

    3 months

Study Arms (3)

Liposomal iron

EXPERIMENTAL

30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.

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.

Drug: Lactoferrin

Iv iron dextran

EXPERIMENTAL

30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.

Drug: Iron Dextran Injection

Interventions

Ferric Pyrophosphate LiposomalDRUG

30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.

Also known as: Novoferr
Liposomal iron
LactoferrinDRUG

30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.

Also known as: Provan
Iron supported Lactoferrin
Iron Dextran InjectionDRUG

30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.

Iv iron dextran

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A) Pediatrics ≤18 year old male and female patients. B) Pediatrics with CKD stages 3-5.

You may not qualify if:

  • A) CKD patients' ≥18 year old. B) Active bleeding C) Malignancy D) Anemia due to any disease other than CKD E) Blood Transfusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 35675292BACKGROUND

  • Ammirati 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.

    PMID: 31939529BACKGROUND

  • Ueda 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.

    PMID: 28302014BACKGROUND

  • Moscheo 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.

    PMID: 35448476BACKGROUND

  • Wojtaszek 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.

    PMID: 33392212BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

LactoferrinIron-Dextran Complex

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesGlycoproteinsGlycoconjugatesCarbohydratesTransferrinsIron-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsLactoglobulinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsGlobulinsMetalloproteinsCoordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharides

Study Officials

  • Sahar K Hagazy, PhD

    Tanta University

    STUDY CHAIR

  • Mohamed SH Al-Haron

    Menoufia University

    STUDY CHAIR

Central Study Contacts

Mai SE Koura, MSc

CONTACT

201274117967dr.pharmasist@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Critical care clinical pharmacist

Study Record Dates

First Submitted

January 15, 2023

First Posted

February 6, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2024

Study Completion

December 31, 2024

Last Updated

February 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share