Oral Iron in Children With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— FeTCh-CKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03991169
• Other study ID #: 1812019836
• Status: Recruiting
• Phase: Phase 4
• Start date: April 19, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: Christopher Tapia, B.S.
• Phone: 212-746-4957
• Email: cht4005[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Chronic Kidney Insufficiency
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine / New York Presbyterian Hospital	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle strength	Hand-grip strength measured by a dynamometer	0 and 3 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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