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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT01265992
Eligibility Criteria:
Inclusion Criteria:
Patients must sign the Informed Consent Form prior to inclusion into the study
* Patients should satisfy the Swedish Summary of Product Characteristics (SPC) for paricalcitol capsules at www.fass.se
* Patients must be 18 years or older with a diagnosis of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 - 5 (estimated Glomerular Filtration Rate between 10-59 by Modification of Diet in Renal Disease) but not yet on dialysis
* Patients should be in stable condition and have a life expectancy of at least 6 months
* Patients should not be expected to be transplanted or initiate dialysis for at least 6 months
Exclusion Criteria:
* Patients with CKD receiving dialysis
* Patients contraindicated for paricalcitol capsules as described in the SPC
* Treatment with paricalcitol more than 20 days prior to study enrollment
* History of drug or alcohol abuse within 6 months prior to inclusion
* History of non-compliance with medication or a medical history (i.e. psychiatric) that could enhance non-compliance with medication as determined by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01265992
Study Brief:
Protocol Section:
NCT01265992