Chronic Kidney InsufficiencyPhase 4FeTCh-CKDNCT03991169
Oral Iron in Children With Chronic Kidney Disease
A Phase 4 study testing Ferrous Sulfate in people with Chronic Kidney Insufficiency and Chronic Kidney Diseases, run by Weill Medical College of Cornell University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Chronic Kidney Insufficiency, Chronic Kidney Diseases
- What is being tested?
- Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2019to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, 10065
Akeem Noziere, B.S., 646-962-8313, akn4001@med.cornell.edu
Oleh Akchurin, M.D.
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Jill Loguidice, 267-425-4541, loguidicej@chop.edu
Amy Kogon, M.D., M.P.H.
About this study
Official title: 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.
- Being tested
- Ferrous Sulfate
- Keywords
- Anemia, Iron, Children, Chronic kidney disease (CKD), Appetite, Physical activity, Muscle strength
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDrug
Also called iron 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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Iron therapy | Experimental | Participant will receive oral iron therapy. Receives: Drug: Ferrous Sulfate |
| No oral iron therapy | No intervention | Participant will not receive oral iron therapy for 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength
Hand-grip strength measured by a dynamometer
Measured: 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
Measured: 0 and 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start19 Apr 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney InsufficiencyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Oleh Akchurin, M.D., Principal investigator, Weill Cornell College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991169
- Sponsor's protocol ID
- 1812019836
- Acronym
- FeTCh-CKD
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2019
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03991169
- Acronym / sponsor ID
- FeTCh-CKD / 1812019836
- Keywords
- Anemia, Iron, Children, Chronic kidney disease (CKD), Appetite, Physical activity, Muscle strength
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Iron therapy | Experimental | Drug: Ferrous SulfateParticipant will receive oral iron therapy. |
| No oral iron therapy | No intervention | –Participant will not receive oral iron therapy for 3 months. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous SulfateAlso: iron sulfateOral 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. | Drug | Oral Iron therapy |
Primary outcome
Change in muscle strength
Time frame: 0 and 3 months
Hand-grip strength measured by a dynamometer
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
4 secondary outcomes
Change in sedentary time
Time frame: 0 and 3 months
Change in the percent of skeletal muscle mass
Time frame: 0 and 3 months
Change in eating behavior
Time frame: 0 and 3 months
Change in quality of life: PROMIS
Time frame: 0 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oleh Akchurin, M.D. principal investigator
Weill Cornell College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous Sulfate in people with Chronic Kidney Insufficiency and Chronic Kidney Diseases, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akeem Noziere, B.S. (646-962-8313, akn4001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle strength (time frame: 0 and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.