Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT (ACTIVE)

Kyowa Kirin

Status and phase: Completed; Phase 4

Conditions: Hyperparathyroidism; Secondary, Renal

Treatments: Drug: Cinacalcet HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT03123406

KKCN201601

Details and patient eligibility

About

1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT;
2. To explore the impact of Cinacalcet HCL using on the combined use of drugs;
3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.

Enrollment: 750 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 3 patient groups

Severe SHPT

Experimental group

Description:

Administer Cinacalcet HCL to subjects whose iPTH\>900 pg/ml from 1st to 32nd week.

Treatment:

Drug: Cinacalcet HCl

Moderate SHPT

Experimental group

Description:

Administer Cinacalcet HCL to subjects whose 600≤iPTH\<900 pg/ml from 1st to 32nd week.

Treatment:

Drug: Cinacalcet HCl

Mild SHPT

Experimental group

Description:

Administer Cinacalcet HCL to subjects whose 300≤iPTH\<600 pg/ml from 1st to 32nd week.

Treatment:

Drug: Cinacalcet HCl