A Phase 4 interventional study of Cinacalcet HCl in Hyperparathyroidism; Secondary, Renal, sponsored by Kyowa Kirin China Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Kyowa Kirin China Pharmaceutical Co., Ltd. (formerly part of Kyowa Kirin Co., Ltd.) · Phase 4, Interventional, and Treatment
Among 28 studies testing cinacalcet in Hyperparathyroidism, Secondary — none open to participants now, none under way, none of them phase 3. Cinacalcet · Hyperparathyroidism, Secondary.
Among the 28 studies testing cinacalcet in Hyperparathyroidism, Secondary, this one is the 2nd largest by enrollment of the 27 interventional ones, is the only one that started in 2017, is one of 13 in phase 4, and was the 28th registered.
188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's enrollment of 750 is above the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.
Browse Hyperparathyroidism, Secondary studies →None of the 28 studies testing cinacalcet in Hyperparathyroidism, Secondary is open now.
Cinacalcet: first FDA approval 2004 (SENSIPAR), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 10 Hyperparathyroidism, Secondary studies recruiting now, 5 (50%) set no upper age limit and 4 (40%) stop at 75 or younger; 4 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2017.
Median enrollment 71 across the 27 interventional studies. Of the 27 that completed or were terminated, 14 (52%) have results posted.
21 of 28 have an industry lead sponsor. The 10 most frequent:
Kyowa Kirin China Pharmaceutical Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Kyowa Kirin China Pharmaceutical Co., Ltd. has 1 study filed under Hyperparathyroidism, Secondary — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 28 studies testing cinacalcet in Hyperparathyroidism, Secondary, from their registry updates:
Nothing recorded among them since 2026-09-25.
188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's enrollment of 750 is above the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.
Browse Hyperparathyroidism, Secondary studies →Kyowa Kirin China Pharmaceutical Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
First submitted before Kyowa Kirin China Pharmaceutical Co., Ltd. left Kyowa Kirin Co., Ltd..
Compared within Hyperparathyroidism, Secondary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hyperparathyroidism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
History of gastrointestinal bleeding or peptic ulcer disease and possibility of deterioration or recurrence;
Severe heart disease;
Epilepsy risk or history of epilepsy;
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administer Cinacalcet HCL to subjects whose iPTH\>900 pg/ml from 1st to 32nd week.
Drug: Cinacalcet HCl
Administer Cinacalcet HCL to subjects whose 600≤iPTH\<900 pg/ml from 1st to 32nd week.
Drug: Cinacalcet HCl
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.
Also known as: Regpara
Compared with baseline data, the proportion of subjects reaching iPTH target at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the proportion of subjects reaching iPTH target at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the proportion of patients reaching Ca & P target simultaneously at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the proportion of patients with ≥ 30% reduction in iPTH level at 32nd week
blood test
Time frame: 32 weeks
The proportion of patients once reaching iPTH target during 1st~32nd week
blood test
Time frame: 32 weeks
The proportion of patients once reaching iPTH target during 33rd~52nd week
blood test
Time frame: 52 weeks
Compared with baseline data, the change of Ca × P at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the change of Ca × P at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the change of alkaline phosphatase (ALP) at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 20th week
blood test
Time frame: 20 weeks
Compared with baseline data, the change of fibroblast growth factor 23(FGF23) at 32nd week
blood test
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 20th week
medication evaluation
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of calcium agents at 32nd week
medication evaluation
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 20th week
medication evaluation
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of phosphate binders at 32nd week
medication evaluation
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 20th week
medication evaluation
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of vitamin D and its analogues at 32nd week
medication evaluation
Time frame: 32 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 20th week
medication evaluation
Time frame: 20 weeks
Compared with baseline data, the adjustment (type or amount) of diphosphonic acid salts at 32nd week
medication evaluation
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
blood test
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
blood test
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
blood test
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
blood test
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
blood test
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
blood test
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
blood test
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
blood test
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
medication evaluation
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
medication evaluation
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
medication evaluation
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
medication evaluation
Time frame: 20 weeks
The reasons of patients discontinuing Cinacalcet in 20-week real world
List presentation
Time frame: 20 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cinacalcet
Hyperparathyroidism, Secondary →
Kyowa Kirin China Pharmaceutical Co., Ltd. →