Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT02492620
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 years at screening visit
2. Serum phosphate \> or equal to 3.0 mg/dL obtained at screening
3. CKD with eGFR \< or equal to 20 mL/min obtained at screening\*
4. Hemoglobin (Hgb) \>8.0 g/dL obtained at screening
5. TSAT \<55% obtained at screening
6. Females of child bearing potential with negative serum pregnancy test obtained at screening
7. Willing and able to give written informed consent
8. Anticipated to have \> or equal to 8 weeks prior to need for initiating RRT in the opinion of the investigator
Exclusion Criteria:
1. Liver enzymes (ALT/AST) \>X3 times upper limit of normal at screening
2. Use of IV iron, blood transfusions or ESA agents within 2 weeks prior to the screening visit and prior to the Day 1 visit.
3. Evidence of acute kidney injury (i.e., no CKD) or planned need for RRT within 12 weeks of screening
4. Scheduled kidney transplant within 24 weeks of screening
5. Contra-indication to ferric citrate: iron overload syndrome, allergic reaction or known intolerance to ferric citrate
6. Clinically significant medical condition felt to interfere with tolerance of oral medication
7. Life expectancy \< 6 months or confirmed conviction that subject does NOT want to initiate RRT despite a decline in kidney function
8. Active drug or alcohol dependence or abuse (excluding tobacco use or marijuana use) within the 12 months prior to screening (in the opinion of the PI)
9. Psychiatric disorder that interferes with the subject's ability to comply with the study protocol in the opinion of the PI
10. Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
11. Inability to cooperate with study personnel or study procedures
12. Females who are pregnant or breastfeeding
13. Receiving or has received any investigational drug with in the past 30 days prior to the Day 1 visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02492620
Study Brief:
Protocol Section:
NCT02492620