Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kyowa Kirin China Pharmaceutical Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\- 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.
You may not be if
\- 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.
Clareo Health | Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
