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OpenTrials
Completed

NCT Number: NCT03123406

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

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.

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Key information

Conditions

Hyperparathyroidism; Secondary, Renal Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease-Mineral and Bone Disorder Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Neoplasm Metastasis Neoplasms Neoplastic Processes Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rickets Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Jinling Hospital

Nanjing, Jiangsu, 210002, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cinacalcet HCl

Drug

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 names: Regpara

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin China Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Acronym: ACTIVE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2017
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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