Oral Iron in Children With Chronic Kidney Disease

NCT03991169 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 1812019836
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

Anemia; Iron; Children; Chronic kidney disease (CKD); Appetite; Physical activity; Muscle strength

Outcome Measures

Primary Outcomes (2)

• Change in muscle strength

  Hand-grip strength measured by a dynamometer

  0 and 3 months

• Change in the percentage of transferrin saturation in the participants' blood

  Transferrin saturation is a medical laboratory value, measured as a percentage. It is the value of serum iron concentration divided by the total iron-binding capacity. For instance, a value of 15% means that 15% of iron-binding sites of transferrin are being occupied by iron. Blood will be collected with the venopuncture used for clinically indicated blood tests at routine clinic visits

  0 and 3 months

Secondary Outcomes (4)

• Change in sedentary time

  0 and 3 months

• Change in the percent of skeletal muscle mass

  0 and 3 months

• Change in eating behavior

  0 and 3 months

• Change in quality of life: PROMIS

  0 and 3 months

Study Arms (2)

Oral Iron therapy

EXPERIMENTAL

Participant will receive oral iron therapy.

Drug: Ferrous Sulfate

No oral iron therapy

NO INTERVENTION

Participant will not receive oral iron therapy for 3 months.

Interventions

Ferrous Sulfate 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.

Also known as: iron sulfate

Oral Iron therapy

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

Weill Cornell Medicine / New York Presbyterian Hospital

New York, New York, 10065, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia; Motor Activity

Interventions

ferrous sulfate; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Oleh Akchurin, M.D.

  Weill Cornell College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akeem Noziere, B.S.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 19, 2019
• Study Start: April 19, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)