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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT07025460
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 19 years
* Diagnosis of chronic kidney disease (CKD) not requiring dialysis
* Estimated glomerular filtration rate (eGFR) ≤ 45 mL/min/1.73 m² (calculated using the MDRD formula)
* Mean hemoglobin (Hb) concentration ≤ 11.5 g/dL during the screening period Hb concentration ≥ 9.5 g/dL during the screening period Stable DARB dosing during screening (defined as \<25% variation in dose)
* Serum ferritin ≥ 100 µg/L or transferrin saturation (TSAT) \> 20%
* Serum vitamin B12 and folate levels above the lower limit of normal (screening only) Provided written informed consent prior to any study-specific procedures
Exclusion Criteria:
* Planned kidney transplantation or prior kidney transplant
* Uncontrolled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 110 mmHg) Acute myocardial infarction or hospitalization for heart failure within the past 12 weeks
* Serum parathyroid hormone (PTH) \> 1500 pg/mL (screening only) Active systemic infection
* Diagnosed hematologic diseases (e.g., sickle cell anemia, myelodysplastic syndrome, leukemia, multiple myeloma, hemolytic anemia)
* Major surgery within 12 weeks prior to screening (excluding vascular access surgery)
* Red blood cell transfusion within 8 weeks before screening or during the study period
* Use of any investigational drug or medical device within 30 days prior to screening or during the study
* Active malignancy not in remission
* Total darbepoetin alfa dose \> 180 mcg in the month prior to enrollment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT07025460
Study Brief:
Protocol Section:
NCT07025460