What this study is
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.
What's being tested
- Ferrous Sulfate
Intervention · DRUG
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 details
- Official title
- Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease
- Sponsor
- Weill Medical College of Cornell University
- Conditions
- Chronic Kidney Insufficiency · Chronic Kidney Diseases
- Enrolling
- 40 people
- Starts
- 2019-04-19
- Est. completion
- 2028-12-31
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Year – 21 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openWeill Cornell Medicine / New York Presbyterian Hospital
New York, New York, United States
- Akeem Noziere, B.S. · Contact646-962-8313akn4001@med.cornell.edu
- Oleh Akchurin, M.D. · Principal investigator
RecruitingChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
- Jill Loguidice · Contact267-425-4541loguidicej@chop.edu
- Amy Kogon, M.D., M.P.H. · Principal investigator
Recruiting
Study team
Sponsor
Weill Medical College of Cornell University
Study ID 1812019836
Principal investigator
Oleh Akchurin, M.D.
Weill Cornell College of Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.