Comparative Study Between Oral Liposomal Iron,Iron Supported Lactoferrin and IV Iron Dextran in CKD Children

• Sponsor: Menoufia University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05714176
• Collaborator: Tanta University (Other)
• Enrollment: 90
• Arms: 3
• Anticipated Duration (Months): 23

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
CKD - Chronic Kidney Disease	Drug: Ferric Pyrophosphate Liposomal; Drug: Lactoferrin; Drug: Iron Dextran Injection	Phase 4

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

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liposomal iron 30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.	Drug: Ferric Pyrophosphate Liposomal; 30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.; Other Names: Novoferr
Experimental: Iron supported Lactoferrin 30 pediatric patients who will receive oral iron supported Lactoferrin iron (Provan) 100 mg/day for 12 weeks.	Drug: Lactoferrin; 30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.; Other Names: Provan
Experimental: Iv iron dextran 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.	Drug: Iron Dextran Injection; 30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Hemoglobin measure [3 months]

   Measure oxygen in blood by measuring hemoglobin by coloremetric assay

Secondary Outcome Measures

1. Biomarkers measure [3 months]

   changes in serum levels of biological biomarkers( measure IL-6, hepcidin and GDF-15 by ELISA assay).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Menoufia University
• Tanta University

Investigators

• Study Chair: Sahar K Hagazy, PhD, Tanta University
• Study Chair: Mohamed SH Al-Haron, Menoufia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 11, 2022

More Information

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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Mai Salah El-Din, Critical care clinical pharmacist, Menoufia University
• ClinicalTrials.gov Identifier: NCT05714176
• Other Study ID Numbers: Iron in CKD children
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Lactoferrin; Dextrans; Iron-Dextran Complex

Study Results

No Results Posted as of Feb 6, 2023