Trial · NCT03280264
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
NCT03280264, Phase 3, Completed, Kyowa Kirin Co., Ltd.; results first posted 2021-05-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism. Trials, record NCT03280264. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03280264
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
- NCT number
- NCT03280264
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 18 participants, actual
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Conditions
- Parathyroid Carcinoma, Primary Hyperparathyroidism
- Interventions
- KHK7580
- First posted
- 2017-09-12
- Last updated
- 2021-05-27
- Results first posted
- 2021-05-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | Up to 24 weeks | |
| Secondary | 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. | up to 24 weeks | |
| Secondary | Serum Corrected Ca Level | up to 52 weeks | |
| Secondary | Serum Intact Parathyroid Hormone Level | up to 52 weeks | |
| Secondary | Serum Whole Parathyroid Hormone Level | up to 52 weeks |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Up to 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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. | up to 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Serum Corrected Ca Level | up to 52 weeks | mg/dL | MEAN | |
| SECONDARY | Serum Intact Parathyroid Hormone Level | up to 52 weeks | pg/dL | MEAN | |
| SECONDARY | Serum Whole Parathyroid Hormone Level | up to 52 weeks | pg/dL | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | KHK7580 (2-24 mg) | 14 | Participants | ||
| 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. | KHK7580 (2-24 mg) | 12 | Participants | ||
| Serum Corrected Ca Level | KHK7580 (2-24 mg) | 9.89 | Standard Deviation 0.60 | mg/dL | |
| Serum Intact Parathyroid Hormone Level | KHK7580 (2-24 mg) | 152.6 | Standard Deviation 97.3 | pg/dL | |
| Serum Whole Parathyroid Hormone Level | KHK7580 (2-24 mg) | 108.9 | Standard Deviation 73.0 | pg/dL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KHK7580 (2-24 mg) | 18 | |
| Overall Study | COMPLETED | KHK7580 (2-24 mg) | 15 | |
| Overall Study | NOT COMPLETED | KHK7580 (2-24 mg) | 3 |
Source ClinicalTrials.gov
Adverse events53
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | KHK7580 (2-24 mg) | 1 | 18 | |
| other | Nephrogenic anaemia | Blood and lymphatic system disorders | KHK7580 (2-24 mg) | 1 | 18 | |
| other | Atrial fibrillation | Cardiac disorders | KHK7580 (2-24 mg) | 1 | 18 | |
| other | Cataract | Eye disorders | KHK7580 (2-24 mg) | 1 | 18 | |
| other | Cataract cortical | Eye disorders | KHK7580 (2-24 mg) | 1 | 18 | |
| other | Ocular hyperaemia | Eye disorders | KHK7580 (2-24 mg) | 1 | 18 | |
| other | Nausea | Gastrointestinal disorders | KHK7580 (2-24 mg) | 3 | 18 | |
| other | Abdominal discomfort | Gastrointestinal disorders | KHK7580 (2-24 mg) | 1 | 18 | |
| other | Abdominal pain lower | Gastrointestinal disorders | KHK7580 (2-24 mg) | 1 | 18 | |
| other | Dental caries | Gastrointestinal disorders | KHK7580 (2-24 mg) | 1 | 18 |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KHK7580 (2-24 mg) | 0 | 18 |
| Total, other adverse events | KHK7580 (2-24 mg) | 18 | 18 |
| Total, serious adverse events | KHK7580 (2-24 mg) | 3 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03280264
GET https://conductscience.org/api/trials/v1/NCT03280264/events?page=2