Oral Iron in Children With Chronic Kidney Disease
Recruiting
Phase 4
Interventional Study
Chronic Kidney Insufficiency
Chronic Kidney Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 21
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Weill Medical College of Cornell University · Other
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About This Trial
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.
Trial Locations
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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 t…
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