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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT02133404
Eligibility Criteria:
Inclusion Criteria:
* Patients who are on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week since before 12-week (84 days) administration and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period
* Patients with secondary hyperparathyroidism
* Patients whose serum iPTH concentration is \>240 pg/mL and corrected serum Ca is ≥ 9.0 mg/dL
* Patients who have had no changes in the following items ≥4-week (28 days).
* Dosage and regimen, including new administration, of active vitamin D, calcitonin preparation, phosphate binder, and medication with phosphate absorption (including foods)
* Ca concentration of the dialysate, membrane area of the dialyzer, and dialysis time of each week
Exclusion Criteria:
* Patients who underwent parathyroid intervention, such as parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT), within 24 weeks (168 days) prior to the administration
* Patients who have primary hyperparathyroidism
* Patients who received bisphosphonate, estrogen preparation, parathyroid hormone within 4 weeks (28 days)
* Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are observed at \>2/3 of all confirmable measurements
* Patients who are complicated by severe heart disorder \[congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction\], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks (84 days) before administration of the study drug
* Patients with hepatic function abnormal (ALT or AST is \>2× ULN, or total bilirubin (T-bil) is \> 1.5 × ULN.)
* Patients with a history of malignant tumor or the patient's condition is complicated by malignant tumor. (However, enrollment is acceptable if the tumor has not relapsed for 5 years or longer.)
* Patients with a history of serious drug allergy including anaphylactic shock
* Patients with a history of drug allergy to Cinacalcet hydrochloride
* Female patients who are potentially child-bearing or lactating, or patients who do not comply with the instructed contraceptive measures
* Patients who were or are currently involved in trials for other investigational drugs or medical devices, or clinical trial for post-marketing study drugs within 12 weeks (84 days) before the study
* Patients who have received ASP7991 in the past
* Patients who were judged ineligible to participate in the study by the
investigator / subinvestigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT02133404
Study Brief:
Protocol Section:
NCT02133404