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

Primary Purpose

Chronic Kidney Insufficiency, Chronic Kidney Diseases

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ferrous Sulfate
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Insufficiency focused on measuring Anemia, Iron, Children, Chronic kidney disease (CKD), Appetite, Physical activity, Muscle strength

Eligibility Criteria

1 Year - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medicine / New York Presbyterian HospitalRecruiting
  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral Iron therapy

No oral iron therapy

Arm Description

Participant will receive oral iron therapy.

Participant will not receive oral iron therapy for 3 months.

Outcomes

Primary Outcome Measures

Change in muscle strength
Hand-grip strength measured by a dynamometer
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

Secondary Outcome Measures

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.
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.
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".
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.

Full Information

First Posted
June 6, 2019
Last Updated
October 3, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT03991169
Brief Title
Oral Iron in Children With Chronic Kidney Disease
Acronym
FeTCh-CKD
Official Title
Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Insufficiency, Chronic Kidney Diseases
Keywords
Anemia, Iron, Children, Chronic kidney disease (CKD), Appetite, Physical activity, Muscle strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Iron therapy
Arm Type
Experimental
Arm Description
Participant will receive oral iron therapy.
Arm Title
No oral iron therapy
Arm Type
No Intervention
Arm Description
Participant will not receive oral iron therapy for 3 months.
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate
Other Intervention Name(s)
iron sulfate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in muscle strength
Description
Hand-grip strength measured by a dynamometer
Time Frame
0 and 3 months
Title
Change in the percentage of transferrin saturation in the participants' blood
Description
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
Time Frame
0 and 3 months
Secondary Outcome Measure Information:
Title
Change in sedentary time
Description
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.
Time Frame
0 and 3 months
Title
Change in the percent of skeletal muscle mass
Description
Percent of skeletal muscle mass out of body weight will be measured using bio-electrical impedance analysis.
Time Frame
0 and 3 months
Title
Change in eating behavior
Description
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".
Time Frame
0 and 3 months
Title
Change in quality of life: PROMIS
Description
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.
Time Frame
0 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Tapia, B.S.
Phone
212-746-4957
Email
cht4005@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleh Akchurin, M.D.
Organizational Affiliation
Weill Cornell College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine / New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Tapia, B.S.
Phone
212-746-4957
Email
cht4005@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Oleh Akchurin, M.D.
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Mazurek
Phone
267-425-4541
Email
MAZUREKJ@EMAIL.CHOP.EDU
First Name & Middle Initial & Last Name & Degree
Amy Kogon, M.D., M.P.H.

12. IPD Sharing Statement

Plan to Share IPD
No

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Oral Iron in Children With Chronic Kidney Disease

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