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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT06288451
Eligibility Criteria:
Inclusion Criteria:
1. Age \>=18 years
2. Kidney failure treated with in-center hemodialysis
3. PTH \>=150 pg/mL x 2 consecutive measures at least 1 month apart or active IV activated vitamin D treatment using the NKC protocol
Exclusion Criteria:
1. History of parathyroidectomy or calciphylaxis
2. Severe secondary hyperparathyroidism (PTH \>=600 pg/mL x 2 consecutive measures at least 1 month apart despite paricalcitol \>=10 mcg 3x/week or doxercalciferol \>=5 mcg 3x/week or cinacalcet \>30 mg/d)
3. Calcium \>9.8 mg/dL
4. Phosphate \>9 mg/dL
5. Cholestyramine, phenytoin/phenobarbital, or ketoconazole use
6. Breast-feeding mothers
7. Inability to provide informed consent and no legally authorized representative
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06288451
Study Brief:
Protocol Section:
NCT06288451