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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT00823303
Eligibility Criteria:
Inclusion Criteria
1. Age \>18; Able to give informed consent
2. Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
3. intact PTH (iPTH) \>120 pg/ml at baseline
4. albumin corrected calcium \> 8.5 mg/dL to \< 10.0 mg/dL at baseline
5. Phosphorus \< 4.6 mg/dL at baseline
6. If on a phosphorus binder; no change in dose within the 4 weeks prior to screening
Exclusion Criteria
1. Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
2. Receiving \>50,000 IU per month of ergocalciferol or \> 1000 IU of cholecalciferol per day within the previous 30 days.
3. history of primary HPT
4. On prednisone \> 30 days within the previous 6 months
5. receiving bisphosphonates or calcitonin within the previous 12 months
6. Non-elective hospitalization within the previous 30 days.
7. Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.
8. History of renal or other organ transplant
9. History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism
10. Receiving cinacalcet within 4 weeks prior to screening.
11. An active drug/alcohol dependence or abuse history
12. History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator
13. Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00823303
Study Brief:
Protocol Section:
NCT00823303