Oral Iron in Children With Chronic Kidney Disease (FeTCh-CKD)

Pilot Pragmatic Clinical Trial of Oral Iron Therapy 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Chronic Kidney Insufficiency
• Intervention / Treatment: Drug: Ferrous Sulfate

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Christopher Tapia, B.S.; Phone Number: 212-746-4957; Email: cht4005@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine / New York Presbyterian Hospital
      • Contact: Christopher Tapia, B.S.; Phone Number: 212-746-4957; Email: cht4005@med.cornell.edu
      • Principal Investigator: Oleh Akchurin, M.D.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • Children's Hospital of Philadelphia
      • Contact: Jill Mazurek; Phone Number: 267-425-4541; Email: MAZUREKJ@EMAIL.CHOP.EDU
      • Principal Investigator: Amy Kogon, M.D., M.P.H.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Iron therapy; Participant will receive oral iron therapy.	Drug: 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.; Other Names: iron sulfate
No Intervention: No oral iron therapy; Participant will not receive oral iron therapy for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sedentary time	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.	0 and 3 months
Change in the percent of skeletal muscle mass	Percent of skeletal muscle mass out of body weight will be measured using bio-electrical impedance analysis.	0 and 3 months
Change in eating behavior	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".	0 and 3 months
Change in quality of life: PROMIS	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.	0 and 3 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Oleh Akchurin, M.D., Weill Cornell College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Children; Anemia; Iron; Physical activity; Muscle strength; Appetite; Chronic kidney disease (CKD)
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: 1812019836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No