Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney DiseasePhase 3NCT04649411
Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
A Phase 3 study testing ferric citrate in people with Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, run by Keryx Biopharmaceuticals.
Trial summary
This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
- What is being tested?
- ferric citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Mar 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: A 24-Week, Open-Label, Randomized, 2-Arm Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).
- Being tested
- ferric citrate, standard of care
- Keywords
- Iron Deficiency Anemia, Non-Dialysis Dependent Chronic Kidney Disease, CKD, ferric citrate, pediatric, dialysis
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferric citrateDrug
Also called KRX-0502
oral tablets
standard of careDrug
administered per the approved label and at the Investigator's discretion
| Study group | Role | What they receive |
|---|---|---|
| Ferric citrate | Experimental | Participants aged 12 to <18 years and 6 to <12 years will receive ferric citrate for 24 weeks at a starting dose based on body weight categories. Receives: Drug: ferric citrate |
| Standard of care | Active comparator | Participants aged 12 to <18 years and 6 to <12 years will receive standard of care treatment for 24 weeks. Receives: Drug: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events
Measured: up to Week 28
Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results
Measured: up to Week 24
Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate
Measured: up to Week 28
Secondary outcomes (6)
Change from Baseline in Hemoglobin to Week 24/Early Termination Visit
Measured: Baseline; Week 24
Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit
Measured: Baseline; Week 24
Change from Baseline in Ferritin to Week 24/Early Termination Visit
Measured: Baseline; Week 24
Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit
Measured: Baseline; Week 24
Change from Baseline in Calcium to Week 24/Early Termination Visit
Measured: Baseline; Week 24
Change from Baseline in Bicarbonate to Week 24/Early Termination Visit
Measured: Baseline; Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Why it stopped: PMR release
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keryx Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Akebia Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649411
- Sponsor's protocol ID
- KRX-0502-309
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Open-Label, Randomized, 2-Arm Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04649411
- Acronym / sponsor ID
- KRX-0502-309
- Keywords
- Iron Deficiency Anemia, Non-Dialysis Dependent Chronic Kidney Disease, CKD, ferric citrate, pediatric, dialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PMR release
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Keryx BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric citrate | Experimental | Drug: ferric citrateParticipants aged 12 to <18 years and 6 to <12 years will receive ferric citrate for 24 weeks at a starting dose based on body weight categories. |
| Standard of care | Active comparator | Drug: standard of careParticipants aged 12 to <18 years and 6 to <12 years will receive standard of care treatment for 24 weeks. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Serum phosphorus level at Screening:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferric citrateAlso: KRX-0502oral tablets | Drug | Ferric citrate |
| standard of careadministered per the approved label and at the Investigator's discretion | Drug | Standard of care |
Primary outcome
Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events
Time frame: up to Week 28
Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results
Time frame: up to Week 24
Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate
Time frame: up to Week 28
6 secondary outcomes
Change from Baseline in Hemoglobin to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Ferritin to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Calcium to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Bicarbonate to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
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Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Akebia Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ferric citrate in people with Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, run by Keryx Biopharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events (time frame: up to Week 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.