NCT03991169 Oral Iron in Children With Chronic Kidney Disease
| NCT ID | NCT03991169 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Chronic Kidney Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2019-04-19 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2019-04-19 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Oleh Akchurin, M.D.
PRINCIPAL INVESTIGATOR
Weill Cornell College of Medicine
Frequently Asked Questions
Who can join the NCT03991169 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 21 Years, studying Chronic Kidney Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03991169 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03991169 currently recruiting?
Yes, NCT03991169 is actively recruiting participants. Contact the research team at akn4001@med.cornell.edu for enrollment information.
Where is the NCT03991169 trial being conducted?
This trial is being conducted at New York, United States, Philadelphia, United States.
Who is sponsoring the NCT03991169 clinical trial?
NCT03991169 is sponsored by Weill Medical College of Cornell University. The principal investigator is Oleh Akchurin, M.D. at Weill Cornell College of Medicine. The trial plans to enroll 40 participants.
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