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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT00824460
Eligibility Criteria:
Main Inclusion Criteria:
* ≥ 18 years of age,
* Receiving stable maintenance hemodialysis 3 times a week
* On restricted phosphate diet at screening and throughout study
* Receiving stable dose of phosphate binder for at least 1 month
* Serum phosphate levels \>1.78 mmol/L
Main Exclusion Criteria:
* Uncontrolled hyperphosphatemia
* Hypercalcemia at screening or during washout
* Serum calcium \< 1.9 mmol/L (\<7.6 mg/dL)
* Severe hyperparathyroidism (iPTH levels \>600 ng/L)
* Pregnancy or lactation
* Iron deficiency anemia
* History of hemochromatosis or ferritin \>800 mg/L,
* Hepatitis B, hepatitis C or other significant concurrent liver disorders
* Known positivity to HIV
* Use of oral iron preparations 1 month before screening,
* Serious medical condition or uncontrolled systemic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00824460
Study Brief:
Protocol Section:
NCT00824460