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

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ClinicalTrials.gov Identifier: NCT03123406
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin China Pharmaceutical Co., LTD.

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism; Secondary, Renal Drug: Cinacalcet HCl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: CKD Hemodialysis Patients with SHPT
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : April 21, 2019
Estimated Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Severe SHPT
Administer Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week.
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.
Other Name: Regpara

Experimental: Moderate SHPT
Administer Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week.
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.
Other Name: Regpara

Experimental: Mild SHPT
Administer Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week.
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.
Other Name: Regpara




Primary Outcome Measures :
  1. Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week [ Time Frame: 20 weeks ]
    blood test

  2. Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week [ Time Frame: 32 weeks ]
    blood test


Secondary Outcome Measures :
  1. Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week [ Time Frame: 32 weeks ]
    blood test

  2. Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week [ Time Frame: 20 weeks ]
    blood test

  3. Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week [ Time Frame: 32 weeks ]
    blood test

  4. The proportion of patients once reaching iPTH target during 1st~32nd week [ Time Frame: 32 weeks ]
    blood test

  5. The proportion of patients once reaching iPTH target during 33rd~52nd week [ Time Frame: 52 weeks ]
    blood test

  6. Compared with baseline data, the change of Ca × P at 20th week [ Time Frame: 20 weeks ]
    blood test

  7. Compared with baseline data, the change of Ca × P at 32nd week [ Time Frame: 32 weeks ]
    blood test

  8. Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week [ Time Frame: 20 weeks ]
    blood test

  9. Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week [ Time Frame: 32 weeks ]
    blood test

  10. Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week [ Time Frame: 20 weeks ]
    blood test

  11. Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week [ Time Frame: 32 weeks ]
    blood test

  12. Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week [ Time Frame: 20 weeks ]
    medication evaluation

  13. Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week [ Time Frame: 32 weeks ]
    medication evaluation

  14. Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week [ Time Frame: 20 weeks ]
    medication evaluation

  15. Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week [ Time Frame: 32 weeks ]
    medication evaluation

  16. Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week [ Time Frame: 20 weeks ]
    medication evaluation

  17. Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week [ Time Frame: 32 weeks ]
    medication evaluation

  18. Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week [ Time Frame: 20 weeks ]
    medication evaluation

  19. Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week [ Time Frame: 32 weeks ]
    medication evaluation

  20. 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 [ Time Frame: 52 weeks ]
    blood test

  21. 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 [ Time Frame: 52 weeks ]
    blood test

  22. 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 [ Time Frame: 52 weeks ]
    blood test

  23. 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 [ Time Frame: 52 weeks ]
    blood test

  24. 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 [ Time Frame: 52 weeks ]
    blood test

  25. 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 [ Time Frame: 52 weeks ]
    blood test

  26. 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 [ Time Frame: 52 weeks ]
    blood test

  27. 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 [ Time Frame: 52 weeks ]
    blood test

  28. 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 [ Time Frame: 20 weeks ]
    medication evaluation

  29. 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 [ Time Frame: 20 weeks ]
    medication evaluation

  30. 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 [ Time Frame: 20 weeks ]
    medication evaluation

  31. 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 [ Time Frame: 20 weeks ]
    medication evaluation

  32. The reasons of patients discontinuing Cinacalcet in 20-week real world [ Time Frame: 20 weeks ]
    List presentation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123406


Contacts
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Contact: Jiayi Lei +8621-50800909 leijiayi@kyowa-kirin.com.cn

Locations
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China, Jiangsu
Nanjing Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Zhihong Liu         
Sponsors and Collaborators
Kyowa Hakko Kirin China Pharmaceutical Co., LTD.
Investigators
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Study Chair: Nanjing China Nanjing Jinling Hospital
Principal Investigator: Shanghai China RenJi Hospital
Principal Investigator: Zhengzhou China Zhengzhou University First Hospital
Principal Investigator: Nanjing China The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Foshan China Foshan First People's Hospital
Principal Investigator: Hefei China Anhui Medical University Second Hospital
Principal Investigator: Chengdu China Sichuan Huaxi Hopsital
Principal Investigator: Xiamen China Xiamen University Zhongshan Hospital
Principal Investigator: Beijing China Peking Union Medical College Hospital
Principal Investigator: Beijing China Beijing Chao Yang Hospital
Principal Investigator: Beijing China Peking University Third Hospital
Principal Investigator: Shanghai China Ruijin Hospital
Principal Investigator: Shanghai China Shanghai Huashan Hospital
Principal Investigator: Beijing China Peking University People's Hospital
Principal Investigator: Tianjin China Tianjin Medical University Second Hospital
Principal Investigator: Wuhan China Hubei People's Hospital
Principal Investigator: Shanghai China Shanghai Fifth People's Hospital
Principal Investigator: Beijing China Beijing Hospital

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Responsible Party: Kyowa Hakko Kirin China Pharmaceutical Co., LTD.
ClinicalTrials.gov Identifier: NCT03123406     History of Changes
Other Study ID Numbers: KKCN201601
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kyowa Hakko Kirin China Pharmaceutical Co., LTD.:
cinacalcet
secondary hyperparathyroidism
calcimimetics
CKD-MBD

Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists