Hyperparathyroidism; Secondary, RenalPhase 4ACTIVENCT03123406

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

A Phase 4 study testing Cinacalcet HCl in people with Hyperparathyroidism; Secondary, Renal, run by Kyowa Kirin China Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hyperparathyroidism; Secondary, Renal
What is being tested?: Cinacalcet HCl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 750 participants
Where: 1 siteChina
Study dates: 19 Apr 2017to 6 Sep 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Nanjing Jinling Hospital
Nanjing, Jiangsu, 210002

Other trials in China

About this study

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)

To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT;
To explore the impact of Cinacalcet HCL using on the combined use of drugs;
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
Being tested: Cinacalcet HCl
Keywords: cinacalcet, secondary hyperparathyroidism, calcimimetics, CKD-MBD
Medical subject headings: Hyperparathyroidism, Neoplasm Metastasis, Hyperparathyroidism, Secondary, Chronic Kidney Disease-Mineral and Bone Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cinacalcet HClDrug
Also called Regpara
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.

Study groups in NCT03123406
Study group	Role	What they receive
Severe SHPT	Experimental	Administer Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week. Receives: Drug: Cinacalcet HCl
Moderate SHPT	Experimental	Administer Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week. Receives: Drug: Cinacalcet HCl
Mild SHPT	Experimental	Administer Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week. Receives: Drug: Cinacalcet HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
blood test
Measured: 20 weeks
Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
blood test
Measured: 32 weeks

Secondary outcomes (32)

Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week
blood test
Measured: 32 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week
blood test
Measured: 20 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week
blood test
Measured: 32 weeks
The proportion of patients once reaching iPTH target during 1st~32nd week
blood test
Measured: 32 weeks
The proportion of patients once reaching iPTH target during 33rd~52nd week
blood test
Measured: 52 weeks
Compared with baseline data, the change of Ca × P at 20th week
blood test
Measured: 20 weeks
Compared with baseline data, the change of Ca × P at 32nd week
blood test
Measured: 32 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week
blood test
Measured: 20 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week
blood test
Measured: 32 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week
blood test
Measured: 20 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week
blood test
Measured: 32 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week
medication evaluation
Measured: 20 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week
medication evaluation
Measured: 32 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week
medication evaluation
Measured: 20 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week
medication evaluation
Measured: 32 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week
medication evaluation
Measured: 20 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week
medication evaluation
Measured: 32 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week
medication evaluation
Measured: 20 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week
medication evaluation
Measured: 32 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 20 weeks
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
Measured: 20 weeks
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
Measured: 20 weeks
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
Measured: 20 weeks
The reasons of patients discontinuing Cinacalcet in 20-week real world
List presentation
Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 20176 Sep 2019

First posted21 Apr 2017
Study start19 Apr 2017
Primary completion20 Apr 2019
Study completion6 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hyperparathyroidism; Secondary, RenalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: CKD Hemodialysis Patients with SHPT
Masking: None (open label)
Enrolment: 750 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03123406
Sponsor's protocol ID: KKCN201601
Acronym: ACTIVE
Status last verified: Apr 2024
First submitted: 29 Mar 2017
Last updated: 29 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

All Hyperparathyroidism; Secondary, Renal trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03123406
Acronym / sponsor ID: ACTIVE / KKCN201601
Conditions: Hyperparathyroidism; Secondary, Renal
Keywords: cinacalcet, secondary hyperparathyroidism, calcimimetics, CKD-MBD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 750 participants (actual)
Lead sponsor: Kyowa Kirin China Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Apr 2017 (actual)
Primary completion: 20 Apr 2019 (actual)
Study completion: 6 Sep 2019 (actual)
First posted: 21 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT;
To explore the impact of Cinacalcet HCL using on the combined use of drugs;
To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: CKD Hemodialysis Patients with SHPT

Arm	Type	Receives
Severe SHPT	Experimental	Drug: Cinacalcet HClAdminister Cinacalcet HCL to subjects whose iPTH>900 pg/ml from 1st to 32nd week.
Moderate SHPT	Experimental	Drug: Cinacalcet HClAdminister Cinacalcet HCL to subjects whose 600≤iPTH<900 pg/ml from 1st to 32nd week.
Mild SHPT	Experimental	Drug: Cinacalcet HClAdminister Cinacalcet HCL to subjects whose 300≤iPTH<600 pg/ml from 1st to 32nd week.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cinacalcet HClAlso: RegparaAdminister 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.	Drug	Mild SHPT, Moderate SHPT, Severe SHPT

Primary outcome

Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
Time frame: 20 weeks
blood test
Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
Time frame: 32 weeks
blood test

32 secondary outcomes

Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week
Time frame: 32 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week
Time frame: 20 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week
Time frame: 32 weeks
The proportion of patients once reaching iPTH target during 1st~32nd week
Time frame: 32 weeks
The proportion of patients once reaching iPTH target during 33rd~52nd week
Time frame: 52 weeks
Compared with baseline data, the change of Ca × P at 20th week
Time frame: 20 weeks
Compared with baseline data, the change of Ca × P at 32nd week
Time frame: 32 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week
Time frame: 20 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week
Time frame: 32 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week
Time frame: 20 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week
Time frame: 32 weeks
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
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
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
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
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
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
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
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
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
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
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
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
The reasons of patients discontinuing Cinacalcet in 20-week real world
Time frame: 20 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
Individual participant dataSharing planned: Undecided

Related trials for Hyperparathyroidism; Secondary, Renal

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhihong Liu study chair

Jinling Hospital, China

Zhaohui Ni principal investigator

RenJi Hospital

Zhangsuo Liu principal investigator

The First Affiliated Hospital of Zhengzhou University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cinacalcet HCl in people with Hyperparathyroidism; Secondary, Renal, run by Kyowa Kirin China Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03123406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.