Oral Iron in Children With Chronic Kidney Disease

NCT ID: NCT03991169

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-19
• Study Completion Date: 2028-12-31

Brief Summary

This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.

Conditions

Chronic Kidney Insufficiency; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Iron therapy

Participant will receive oral iron therapy.

Group Type: EXPERIMENTAL

Ferrous Sulfate

Intervention Type: DRUG

Oral iron will be given in the form of immediate-release iron sulfate, 3-6 mg/kg/day of elemental iron to children with body weight ≤43 kg, and 65 mg of elemental iron (325 mg of iron sulfate) to children with body weight \>43 kg.

No oral iron therapy

Participant will not receive oral iron therapy for 3 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ferrous Sulfate

Oral iron will be given in the form of immediate-release iron sulfate, 3-6 mg/kg/day of elemental iron to children with body weight ≤43 kg, and 65 mg of elemental iron (325 mg of iron sulfate) to children with body weight \>43 kg.

Intervention Type: DRUG

Other Intervention Names

iron sulfate

Eligibility Criteria

Inclusion Criteria

• Age 1-21 years old (muscle strength will be assessed only in children >3 year old)
• Estimated glomerular filtration rate (GFR) < 90 ml/min/1.73m2 by bedside Schwartz formula [height (cm) *0.413 / serum creatinine (mg/dL)]
• Hemoglobin (Hb) more or equal than 9.0 at the previous clinic visit
• Hb less than 11.5 g/dL in children younger than 5 years Hb less than 12.0 g/dL in children 5-12 years Hb <12.5 g/dL in children 12-15 yrs and females >15 yrs. Hb <13.5 g/dL in males >15 years (all at the previous clinic visit)

Children with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng/mL will be randomized into one of the arms

Exclusion Criteria

• Transferrin saturation <5%
• Serum ferritin < 10 ng/mL
• Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization
• Blood transfusion within 4 months prior to enrollment
• Children on hemodialysis
• Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months
• Pregnancy and breast-feeding

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oleh Akchurin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell College of Medicine

Locations

Weill Cornell Medicine / New York Presbyterian Hospital

New York, New York, United States

Site Status: RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Akeem Noziere, B.S.

Role: CONTACT

akn4001@med.cornell.edu

646-962-8313

Facility Contacts

Akeem Noziere, B.S.

Role: primary

akn4001@med.cornell.edu

646-962-8313

Jill Loguidice

Role: primary

loguidicej@chop.edu

267-425-4541

Other Identifiers

1812019836

Identifier Type: -

Identifier Source: org_study_id