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

NCT ID: NCT05714176

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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

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CKD - Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liposomal iron

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

Group Type EXPERIMENTAL

Ferric Pyrophosphate Liposomal

Intervention Type DRUG

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

Iron supported Lactoferrin

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

Group Type EXPERIMENTAL

Lactoferrin

Intervention Type DRUG

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

Iv iron dextran

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

Group Type EXPERIMENTAL

Iron Dextran Injection

Intervention Type DRUG

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

Interventions

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Ferric Pyrophosphate Liposomal

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

Intervention Type DRUG

Lactoferrin

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

Intervention Type DRUG

Iron Dextran Injection

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

Intervention Type DRUG

Other Intervention Names

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Novoferr Provan

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Mai Salah El-Din

Critical care clinical pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sahar K Hagazy, PhD

Role: STUDY_CHAIR

Tanta University

Mohamed SH Al-Haron

Role: STUDY_CHAIR

Menoufia University

Central Contacts

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Mai SE Koura, MSc

Role: CONTACT

201274117967

References

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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.

Reference Type BACKGROUND
PMID: 35675292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31939529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28302014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35448476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33392212 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Iron in CKD children

Identifier Type: -

Identifier Source: org_study_id

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