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Oral Iron in Children With Chronic Kidney Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Oral Iron in Children With Chronic Kidney Disease

Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease

NCT03991169•Weill Medical College of Cornell University

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.

Eligibility

Age

1 - 21 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Weill Cornell Medicine / New York Presbyterian Hospital

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 19, 2019

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

August 11, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Kidney InsufficiencyChronic Kidney Diseases

Interventions

Ferrous Sulfate

DRUG

Contacts

Akeem Noziere, B.S.

CONTACT

646-962-8313 akn4001@med.cornell.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Oral Iron in Children With Chronic Kidney Disease

Inclusion Criteria

Exclusion Criteria

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