Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
Iron in CKD children
Description
This is a randomized, parallel study that will be conducted on pediatric patients with CKD.
Trial arms
Trial start
2023-02-01
Estimated PCD
2024-01-01
Trial end
2024-12-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Ferric Pyrophosphate Liposomal
30 pediatric patients who will receive oral liposomal iron (Novoferr) 30 mg/day for 12 weeks.
Arms:
Liposomal iron
Other names:
Novoferr
Lactoferrin
30 pediatric patients who will receive oral iron supported Lactoferrin (Provan) 100 mg/day for 12 weeks.
Arms:
Iron supported Lactoferrin
Other names:
Provan
Iron Dextran Injection
30 pediatric patients who will receive IV iron dextran 50 mg /3 times weekly for 12 weeks.
Arms:
Iv iron dextran
Size
90
Primary endpoint
Hemoglobin measure
3 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-02-06

1 organization

3 products

1 indication

Organization
Menoufia University
Product
Ferric Pyrophosphate Liposomal
Indication
CKD - Chronic Kidney Disease
Product
Lactoferrin
Product
Iron Dextran