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

Hyperparathyroidism; Secondary, Renal Clinical Trial

— ACTIVE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123406
• Other study ID #: KKCN201601
• Status: Completed
• Phase: Phase 4
• Start date: April 19, 2017
• Est. completion date: September 6, 2019

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: September 6, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Hyperparathyroidism; Secondary, Renal
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin China Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week	blood test	20 weeks
Primary	Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week	blood test	32 weeks
Secondary	Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week	blood test	32 weeks
Secondary	Compared with baseline data, the proportion of patients with = 30% reduction in iPTH level at 20th week	blood test	20 weeks
Secondary	Compared with baseline data, the proportion of patients with = 30% reduction in iPTH level at 32nd week	blood test	32 weeks
Secondary	The proportion of patients once reaching iPTH target during 1st~32nd week	blood test	32 weeks
Secondary	The proportion of patients once reaching iPTH target during 33rd~52nd week	blood test	52 weeks
Secondary	Compared with baseline data, the change of Ca × P at 20th week	blood test	20 weeks
Secondary	Compared with baseline data, the change of Ca × P at 32nd week	blood test	32 weeks
Secondary	Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week	blood test	20 weeks
Secondary	Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week	blood test	32 weeks
Secondary	Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week	blood test	20 weeks
Secondary	Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week	blood test	32 weeks
Secondary	Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week	medication evaluation	20 weeks
Secondary	Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week	medication evaluation	32 weeks
Secondary	Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week	medication evaluation	20 weeks
Secondary	Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week	medication evaluation	32 weeks
Secondary	Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week	medication evaluation	20 weeks
Secondary	Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week	medication evaluation	32 weeks
Secondary	Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week	medication evaluation	20 weeks
Secondary	Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week	medication evaluation	32 weeks
Secondary	Compared with the data at 32nd week, the proportional change of patients reaching iPTH target at 52nd week who continue Cinacalcet treatment during 20-week real world period	blood test	52 weeks
Secondary	Compared with the data at 32nd week, the proportional change of patients reaching iPTH target at 52nd week who discontinue Cinacalcet treatment after 20-week real world period	blood test	52 weeks
Secondary	Compared with the data at 32nd week, the proportional change of patients reaching Ca target at 52nd week who continue Cinacalcet treatment after 20-week real world period	blood test	52 weeks
Secondary	Compared with the data at 32nd week, the proportional change of patients reaching Ca target at 52nd week who discontinue Cinacalcet treatment after 20-week real world period	blood test	52 weeks
Secondary	Compared with the data at 32nd week, the proportional change of patients reaching P target at 52nd week who continue Cinacalcet treatment after 20-week real world period	blood test	52 weeks
Secondary	Compared with the data at 32nd week, the proportional change of patients reaching P target at 52nd week who discontinue Cinacalcet treatment after 20-week real world period	blood test	52 weeks
Secondary	Compared with the data at 32nd week, the proportional change of patients reaching Ca × P target at 52nd week who continue Cinacalcet treatment after 20-week real world period	blood test	52 weeks
Secondary	Compared with the data at 32nd week, the proportional change of patients reaching Ca × P target at 52nd week who discontinue Cinacalcet treatment after 20-week real world period	blood test	52 weeks
Secondary	The dose change of calcium agents which were used by patients for chronic kidney disease-mineral and bone disorder(CKD-MBD) treatment during 20-week real world period	medication evaluation	20 weeks
Secondary	The dose change of phosphate binders which were used by patients for chronic kidney disease-mineral and bone disorder(CKD-MBD) treatment during 20-week real world period	medication evaluation	20 weeks
Secondary	The dose change of vitamin D and its analogues which were used by patients for chronic kidney disease-mineral and bone disorder(CKD-MBD) treatment during 20-week real world period	medication evaluation	20 weeks
Secondary	The dose change of diphosphonic acid salts which were used by patients for chronic kidney disease-mineral and bone disorder(CKD-MBD) treatment during 20-week real world period	medication evaluation	20 weeks
Secondary	The reasons of patients discontinuing Cinacalcet in 20-week real world	List presentation	20 weeks