Oral iron therapy for children with chronic kidney disease
Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease
This study is testing if giving oral iron supplements to children with chronic kidney disease and mild anemia can help improve their strength, activity levels, and eating habits.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT03991169 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial investigates the effects of oral iron therapy using ferrous sulfate in children aged 1-21 years with chronic kidney disease (CKD) and mild anemia. Participants will be randomly assigned to receive either standard iron sulfate treatment or no iron therapy for a duration of three months. The study aims to evaluate outcomes such as muscle strength, physical activity, and changes in eating behavior, measured at the start and end of the trial. The goal is to determine the efficacy of oral iron in improving health metrics in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 1-21 years with chronic kidney disease and mild anemia, specifically those with certain hemoglobin and transferrin saturation levels.
Not a fit: Patients who have severe iron deficiency or are currently receiving iron therapy or erythropoietin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of anemia in children with chronic kidney disease, enhancing their overall health and quality of life.
How similar studies have performed: Other studies have explored iron therapy in similar populations, showing promising results, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 1 other locations
- Weill Cornell Medicine / New York Presbyterian Hospital — New York, New York, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Oleh Akchurin, M.D. — Weill Cornell College of Medicine
- Study coordinator: Akeem Noziere, B.S.
- Email: akn4001@med.cornell.edu
- Phone: 646-962-8313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.