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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT00686751
Eligibility Criteria:
Inclusion Criteria:
* Patient stable on chronic hemodialysis for more than 3 months.
* PTH level between 150 - 800 pg/ml.
* Ability to give informed consent.
* Serum calcium levels (corrected for albumin level of 4.0 g/dL) less than 10.5 mg/dL for the last three consecutive measurements.
* Serum Phosphorus levels between 2.5 and 7.0 mg/dL for the last three consecutive measurements.
* Ca x P-Product of less than 75 mg2/dL2 in the last three consecutive measurements.
Exclusion Criteria:
* Known active malignancy.
* Liver disease defined as serum aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyltransferase levels more than 2 times the upper limits of normal.
* PTH levels between 150 pg/mL and 800 pg/mL.
* Hypercalcemia or hypercalcemic episodes within the last 4 weeks.
* Ca x P-Product more than 75 mg2/dL2 within the last 4 weeks.
* Any clinical significant infections which are or have been treated with antibiotics within 6 weeks prior to start of the study.
* Chronic viral infection (HIV, Hepatitis B or C).
* Currently on immunosuppressive medication (steroids, cyclosporine, etc…).
* Hematocrit less than 30 %.
* History of blood disorders other than renal anemia.
* Age of less than 18 years or more than 75 years.
* Hypersensitivity to paricalcitol or any ingredient of the product.
* Parathyroidectomy.
* Participation in another study at the same time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00686751
Study Brief:
Protocol Section:
NCT00686751