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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT02018133
Eligibility Criteria:
Inclusion Criteria:
* Chronic kidney disease stage 3/4
* PTH: \>70 pg/ml
* If on ACEI/ARB, optimized and stable dose
Exclusion Criteria:
* Failure to provide informed consent
* Prior active vitamin D oral or parenteral treatment, including calcitriol, paricalcitol and doxercalciferol
* Glomerulonephritis requiring active treatment with immunosuppressive therapy
* Serum phosphorus: \> 5.2 mg/dL
* Serum calcium (corrected for albumin): \> 10.0 mg/dL
* Clinical unstable medical conditions (other than CKD)
* Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
* History of malignancy, other than basal cell carcinoma of the skin
* History of hypersensitivity to vitamin D or its analogs
* Pregnant or nursing (lactating) women
* Women of child-bearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02018133
Study Brief:
Protocol Section:
NCT02018133