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New treatment option for Chronic Kidney Insufficiency
Official title Oral Iron in Children With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT03991169
What this study is testing
What is Ferrous Sulfate?
Ferrous Sulfate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney insufficiency.
Also referred to as iron sulfate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 21
You may be able to join 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 \ 15 yrs. Hb \ 15 years (all at the previous...
You likely 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
See the full eligibility 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 \ 15 yrs. Hb \ 15 years (all at the previous clinic visit) Children with transferrin saturation ≤ 20% AND serum...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.