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:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT02661295
Eligibility Criteria:
Inclusion Criteria:
* Hemodialysis treatment for ≥ 6 months
* Phosphate binder treatment for ≥ to 1 month
* Maintenance iron therapy with no more than 125mg IV iron weekly≥ to 1 month
* Serum phosphorus levels between 2.5 and 8 at screening
* Serum phosphorus ≥ to 6.0 mg/dL after a 2 week washout period.
* Serum ferritin ≥ 200 and \< 600ng/ml after a 2 week washout period
* Serum calcium levels within normal range
* Predicted survival greater than 6 months
Exclusion Criteria:
* Intact PTH\< 70 pg/ml or \> 1,000 pg/ml
* Oral iron use
* Vitamin C supplement use
* Parathyroidectomy
* Active malignancy
* Hemodialysis via an intravenous catheter or arteriovenous (AV) graft
* Received \> 250mg of IV iron over the two weeks prior to screening
* Whole blood transfusion within 3 months prior to screening
* Active bleeding other than from the dialysis access
* Hospitalization within one month prior to screening
* current infection
* Ongoing or uncontrolled inflammatory disorder
* Liver cirrhosis
* Likelihood of imminent renal transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02661295
Study Brief:
Protocol Section:
NCT02661295