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NCT03123406: ACTIVE

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

Completed Phase 4 Last updated 29 April 2024
What this trial tests

Phase 4 trial testing Cinacalcet HCl in Hyperparathyroidism; Secondary, Renal in 750 participants. Completed in 6 September 2019.

Timeline
19 April 2017
Primary endpoint
20 April 2019
6 September 2019

Quick facts

Lead sponsorKyowa Kirin China Pharmaceutical Co., Ltd.
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment750
Start date19 April 2017
Primary completion20 April 2019
Estimated completion6 September 2019
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Kyowa Kirin China Pharmaceutical Co., Ltd.

Who can join

Adults 18 to 75, any sex, with Hyperparathyroidism; Secondary, Renal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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