Iron pill trial for kids with kidney disease pulled before start
NCT ID NCT04649411
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was designed to test the safety of an iron pill called ferric citrate in children aged 6 to 17 with iron deficiency anemia and chronic kidney disease (not on dialysis). The plan was to compare the iron pill to standard care over 24 weeks. However, the study was withdrawn before any participants were enrolled, so no data were collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ferric citrate (an iron pill)
- What this could lead to
- If it works, this could offer a safe way to treat iron deficiency anemia in children with chronic kidney disease without dialysis.
- What could go wrong
- The study was withdrawn before enrolling anyone, so no results are available. It is unclear if ferric citrate is safe or effective in this age group.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Expected to start
-
Jan 2025
An estimate. Start dates often move.
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 18 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 6 years to \<18 years at Screening * Body Weight ≥12 kilograms (kg) at Screening * Chronic kidney disease (CKD) stage 3 to 5, not on dialysis, with estimated glomerular filtration rate (eGFR) \<60 milliliters per minute (mL/min)/1.73 meters squared (m\^2) utilizing the "Bedside Schwartz" equation * Hemoglobin (Hgb) ≥8.5 and ≤11.5 grams per deciliter (g/dL) at Screening * Transferrin saturation (TSAT) ≤25% at Screening * Ferritin ≤200 nanograms per milliliter (ng/mL) at Screening Exclusion Criteria: * Serum phosphorus level at Screening: * 6 to \<13 years: ≤4.0 milligrams per deciliter (mg/dL); * 13 to \<18 years: ≤2.7 mg/dL * Liver transaminases (aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\]) ˃3× the upper limit of normal at Screening * Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease * Unable to swallow pills * Anemia due to causes other than iron deficiency anemia (IDA) of CKD * Intravenous iron therapy or blood transfusion within 4 weeks before the Screening visit * Participants with a functioning organ transplant * Receipt of any investigational drug within 4 weeks before Screening * Phosphate binder use during the Screening period
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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