NCT03991169RecruitingPhase 4
Oral Iron in Children With Chronic Kidney Disease
Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 6 Jun 2019
- Start date
- 19 Apr 2019
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Chronic kidney disease
- NCT number
- NCT03991169
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 19 Apr 2019 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization
- Blood transfusion within 4 months prior to enrollment
- Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months
Lab values
- Serum ferritin \< 10 ng/mL
Other
- Transferrin saturation \<5%
- Children on hemodialysis
- Pregnancy and breast-feeding
Who the study is looking for
- 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
Age in the registry: 1 year to 21 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine-New York Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.