NCT03123406

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

A Multi-center Study Evaluating Efficacy and Safety of Cinacalcet Hydrochloride(HCL) in Calcium, Phosphorus and Intact Parathyroid Hormone(iPTH) Serum Levels in Chinese Chronic Kidney Disease(CKD) Hemodialysis(HD) Patients With Mild, Moderate and Severe Secondary Hyperparathyroidism(SHPT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Kyowa Kirin China Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hyperparathyroidism; Secondary, Renal

Interventions

Type	Name	Description
DRUG	Cinacalcet HCl	Administer Cinacalcet HCL to all subjects from 1st to 32nd week. Subjects choose to buy and take Cinacalcet HCL in real-world period from 33rd to 52nd week.

Timeline

• Start date: 2017-04-19
• Primary completion: 2019-04-20
• Completion: 2019-09-06
• First posted: 2017-04-21
• Last updated: 2024-04-29

Locations

1 site across 1 country: China