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NCT Number: NCT03991169

Oral Iron in Children With Chronic Kidney Disease

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.

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Key information

Conditions

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

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weill Cornell Medicine / New York Presbyterian Hospital, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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

Treatment and study plan

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.

Other names: iron sulfate

Primary outcomes

  1. Change in muscle strength

    Time frame: 0 and 3 months

    Hand-grip strength measured by a dynamometer

  2. Change in the percentage of transferrin saturation in the participants' blood

    Time frame: 0 and 3 months

    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

Secondary outcomes

  1. Change in sedentary time

    Time frame: 0 and 3 months

    Sedentary time (in minutes per day) will be measured by actigraphy. Actigraph is a monitor that looks like a wristband or a watch that measures and records body movements throughout the day. Participating children will wear actigraphs for 7 days in the beginning and 7 days at the conclusion of the study.

  2. Change in the percent of skeletal muscle mass

    Time frame: 0 and 3 months

    Percent of skeletal muscle mass out of body weight will be measured using bio-electrical impedance analysis.

  3. Change in eating behavior

    Time frame: 0 and 3 months

    Appetite / eating behavior assessed using Children's Eating Behavior Questionnaire (CEBQ). It is a parent-report measure comprised of 35 items, each rated as "Never", "Rarely", "Sometimes", "Often", "Always". The answers will be grouped into the domains to assess eating styles of the participating children, such as: "Enjoyment of food", "Slowness in eating", "Emotional under-eating", "Food fussiness".

  4. Change in quality of life: PROMIS

    Time frame: 0 and 3 months

    Quality of life will be assessed in the Fatigue, and Physical Activity domains using the Patient-Reported Outcomes Measurement Information System (PROMIS), developed by the National Institutes of Health. PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.

    Higher scores will mean more Fatigue and more Physical Activity respectively.

Study contacts

Contact information is provided by the study sponsor or research team.

Akeem Noziere, B.S.

CONTACT

[email protected]

646-962-8313

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

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

Acronym: FeTCh-CKD

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jun 19, 2019
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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