A Phase 3 interventional study of KHK7580 in Parathyroid Carcinoma and Primary Hyperparathyroidism, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 3, Interventional, and Treatment
To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
63 studies on the registry are indexed under Parathyroid Neoplasms; 19 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 38 interventional studies indexed under Parathyroid Neoplasms.
Browse Parathyroid Neoplasms studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 159 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
oral administration
Drug: KHK7580
oral administration
Also known as: evocalcet
The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.
Time frame: Up to 24 weeks
The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.
Time frame: up to 24 weeks
Serum Corrected Ca Level
Time frame: up to 52 weeks
Serum Intact Parathyroid Hormone Level
Time frame: up to 52 weeks
Serum Whole Parathyroid Hormone Level
Time frame: up to 52 weeks
| Milestone | KHK7580 (2-24 mg) |
|---|---|
| Started | 18 |
| Completed | 15 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Participants | KHK7580 (2-24 mg) |
|---|---|
| The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase. | 14 |
| Participants | KHK7580 (2-24 mg) |
|---|---|
| The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase. | 12 |
| mg/dL | KHK7580 (2-24 mg) |
|---|---|
| Serum Corrected Ca Level | 9.89 ± 0.60 |
| pg/dL | KHK7580 (2-24 mg) |
|---|---|
| Serum Intact Parathyroid Hormone Level | 152.6 ± 97.3 |
| pg/dL | KHK7580 (2-24 mg) |
|---|---|
| Serum Whole Parathyroid Hormone Level | 108.9 ± 73.0 |
Collected over up to 52week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KHK7580 (2-24 mg) | 0/18 (0%) | 3/18 (16.7%) | 18/18 (100%) |
| Event | KHK7580 (2-24 mg) |
|---|---|
| enterocolitisGastrointestinal disorders | 1/18 |
| urinary tract infectionRenal and urinary disorders | 1/18 |
| uterine cancerReproductive system and breast disorders | 1/18 |
| Event | KHK7580 (2-24 mg) |
|---|---|
| NasopharyngitisInfections and infestations | 7/18 |
| NauseaGastrointestinal disorders | 3/18 |
| Chest painGeneral disorders | 2/18 |
| CystitisInfections and infestations | 2/18 |
| InfluenzaInfections and infestations | 2/18 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/18 |
| Back painMusculoskeletal and connective tissue disorders | 2/18 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/18 |
| HeadacheNervous system disorders | 2/18 |
| Iron deficiency anaemiaBlood and lymphatic system disorders | 1/18 |
| Age, Continuous(years) | KHK7580 (2-24 mg) |
|---|---|
| Mean | 62.2 ± 11.9 |
| Sex: Female, Male(Participants) | KHK7580 (2-24 mg) |
|---|---|
| Female | 13 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | KHK7580 (2-24 mg) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 18 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | KHK7580 (2-24 mg) |
|---|---|
| Japan | 18 |
| serum corrected Ca conc.(mg/dL) | KHK7580 (2-24 mg) |
|---|---|
| Mean | 11.73 ± 0.84 |
| serum intact Parathyroid Hormone conc.(pg/mL) | KHK7580 (2-24 mg) |
|---|---|
| Mean | 507.7 ± 1409.8 |
| parathyroid carcinoma(Participants) | KHK7580 (2-24 mg) |
|---|---|
| Count of participants | 3 |
| Unable to undergo parathyroidectomy(participants) | KHK7580 (2-24 mg) |
|---|---|
| Number | 13 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Evocalcet