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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01573520
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Patients on hemodialysis since more than 3 months
* Patients with secondary hyperparathyroidism treated with Cinacalcet-HCl at a stable dose (30mg/day or more) for at least 1 month before enrolment and indication to Cinacalcet-HCL therapy (iPTH in target values or over target values)
* Patients with secondary hyperparathyroidism with indication to be treated with Cinacalcet-HCL (iPTH ≥ locally pre-defined targets). In this case, patients should be treated at least 1 month with stable dose Cinacalcet-HCL before enrolment
Exclusion Criteria:
* Intolerance to Cincalcet-HCL
* Inability to understand the protocol
* Mental diseases
* Patients suffering from cancer or having a short life expectancy (\<6 months)
* Patients planned for a parathyroidectomy
* Patients having had a parathyroidectomy
* Patient already enrolled in a Cinacalcet-HCL protocol
* Symptomatic hypocalcaemia or total serum calcium \< 1.87 mmol/l
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01573520
Study Brief:
Protocol Section:
NCT01573520