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:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 3:59 PM
NCT ID:
NCT03123406
Eligibility Criteria:
Inclusion Criteria:
\- Parents/guardians must sign informed consent;
Must be males or females whose age are 18 to 75 years old;
Clinical diagnosis of chronic kidney disease on maintenance hemodialysis with secondary hyperparathyroidism;
iPTH must be equal or higher than 300Pg/ml;
Must not have received Calcimimetics(for example, Cinacalcet) within 6 months prior to enrollment;
Must have been on maintenance hemodialysis 3 times weekly (TIW) for at least 3 months(12 weeks) prior to enrollment and must be expected to remain on hemodialysis for the duration of the study;
Over 2-year life expectancy.
Exclusion Criteria:
\- Hypocalcemia \[Corrected serum calcium level less than 2.1mmol/L(8.4mg/dL);
History of gastrointestinal bleeding or peptic ulcer disease and possibility of deterioration or recurrence;
Severe heart disease;
Epilepsy risk or history of epilepsy;
Hypersensitivity to Cinacalcet;
Drug abuse/addiction;
Plan to receive renal transplantation within 52 weeks;
Pregnant or lactating women;
Pregnancy plan within 1 years, or no guarantee on taking effective contraceptive measures within 1 year after enrollment;
Participated in other clinical trials within 4 weeks prior to enrollment;
Received parathyroidectomy within 24 weeks prior to enrollment;
Investigator judgment that patients are not suitable to enroll.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03123406
Study Brief:
Protocol Section:
NCT03123406