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

Primary Purpose

CKD - Chronic Kidney Disease

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Ferric Pyrophosphate Liposomal

Lactoferrin

Iron Dextran Injection

About this trial

This is an interventional treatment trial for CKD - Chronic Kidney Disease

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A) Pediatrics ≤18 year old male and female patients. B) Pediatrics with CKD stages 3-5. Exclusion Criteria: A) CKD patients' ≥18 year old. B) Active bleeding C) Malignancy D) Anemia due to any disease other than CKD E) Blood Transfusions

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Liposomal iron

Iron supported Lactoferrin

Iv iron dextran

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Hemoglobin measure

Measure oxygen in blood by measuring hemoglobin by coloremetric assay

Secondary Outcome Measures

Biomarkers measure

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

Full Information

NCT ID

NCT05714176

First Posted

January 15, 2023

Last Updated

January 26, 2023

Sponsor

Menoufia University

Collaborators

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05714176

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 1, 2023 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

Collaborators

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CKD - Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Liposomal iron

Arm Type

Experimental

Arm Description

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

Arm Title

Iron supported Lactoferrin

Arm Type

Experimental

Arm Description

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

Arm Title

Iv iron dextran

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ferric Pyrophosphate Liposomal

Other Intervention Name(s)

Novoferr

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Lactoferrin

Other Intervention Name(s)

Provan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Iron Dextran Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Hemoglobin measure

Description

Measure oxygen in blood by measuring hemoglobin by coloremetric assay

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Biomarkers measure

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mai SE Koura, MSc

Phone

201274117967

dr.pharmasist@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sahar K Hagazy, PhD

Organizational Affiliation

Tanta University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohamed SH Al-Haron

Organizational Affiliation

Menoufia University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35675292

Citation

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.

Results Reference

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PubMed Identifier

31939529

Citation

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.

Results Reference

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PubMed Identifier

28302014

Citation

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.

Results Reference

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PubMed Identifier

35448476

Citation

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.

Results Reference

background

PubMed Identifier

33392212

Citation

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.

Results Reference

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

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