Trial · NCT02312687
Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)
NCT02312687, Phase 2, Completed, Kyowa Kirin, Inc.; results first posted 2019-12-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH). Trials, record NCT02312687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02312687
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)
- NCT number
- NCT02312687
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Kyowa Kirin, Inc.
- Conditions
- X-Linked Hypophosphatemia
- Interventions
- KRN23
- First posted
- 2014-12-09
- Last updated
- 2024-05-06
- Results first posted
- 2019-12-16
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks). | An AE is defined as any untoward medical occurrence, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; an important medical event. A TEAE is an AE that occurred on or after the first burosumab dose. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). AEs were classified by the Investigator as possibly related, probably related, or definitely related. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Through Week 184 | Clinically significant changes from baseline reported as adverse events are presented. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category | Through Week 184 | Clinically significant changes from baseline reported as adverse events are presented. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category | Through Week 184 | Clinically significant changes from baseline reported as adverse events are presented. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests | Through Week 184 | Clinically significant changes from baseline reported as adverse events are presented. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in ECGs | Through Week 184 | Clinically significant changes from baseline reported as adverse events are presented. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category | Through Week 184 | Clinically significant changes from baseline reported as adverse events are presented. |
| Primary | Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline | Through Week 184 | |
| Primary | Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing | Through Week 184 | |
| Primary | Change From Baseline Over Time in Serum Phosphorus | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks). | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Through Week 184 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category | Through Week 184 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category | Through Week 184 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests | Through Week 184 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in ECGs | Through Week 184 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category | Through Week 184 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline | Through Week 184 | Participants tested for neutralizing antibodies (n=4) are those who were positive for anti-KRN23 antibodies at any time during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing | Through Week 184 | Pharmacodynamic (PD) Analysis Set: all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data. | percentage of participants | NUMBER |
| PRIMARY | Change From Baseline Over Time in Serum Phosphorus | Baseline, Weeks 24, 48, 72, 96, 120, 144 | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | mg/dL | LEAST_SQUARES_MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | KRN23 | All AEs | 20 | Participants | |
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | KRN23 | TEAEs | 20 | Participants | |
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | KRN23 | Related AEs | 12 | Participants | |
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | KRN23 | SAEs | 9 | Participants | |
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | KRN23 | Related SAEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | KRN23 | Grade 3 and 4 AEs | 10 | Participants | |
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | KRN23 | AEs Leading to Discontinuation | 0 | Participants | |
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | KRN23 | AEs Leading to Death | 0 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | KRN23 | Hypertension | 2 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | KRN23 | Decreased blood pressure | 1 | Participants |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KRN23 | 20 | |
| Overall Study | COMPLETED | KRN23 | 19 | |
| Overall Study | NOT COMPLETED | KRN23 | 1 |
Source ClinicalTrials.gov
Adverse events223
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 | Atrial Fibrillation | Cardiac disorders | KRN23 | 1 | 20 | |
| other | Palpitations | Cardiac disorders | KRN23 | 1 | 20 | |
| other | Hypoacusis | Ear and labyrinth disorders | KRN23 | 2 | 20 | |
| other | Tinnitus | Ear and labyrinth disorders | KRN23 | 1 | 20 | |
| other | Vertigo | Ear and labyrinth disorders | KRN23 | 3 | 20 | |
| other | Vertigo Positional | Ear and labyrinth disorders | KRN23 | 1 | 20 | |
| other | Hyperparathyroidism | Endocrine disorders | KRN23 | 1 | 20 | |
| other | Cataract | Eye disorders | KRN23 | 2 | 20 | |
| other | Conjunctival Haemorrhage | Eye disorders | KRN23 | 1 | 20 | |
| other | Diplopia | Eye disorders | KRN23 | 1 | 20 |
1 to 10 of 223Source ClinicalTrials.gov
See all 223 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KRN23 | 0 | 20 |
| Total, other adverse events | KRN23 | 20 | 20 |
| Total, serious adverse events | KRN23 | 9 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36072994 | DERIVED |
Source PubMed
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/NCT02312687
GET https://conductscience.org/api/trials/v1/NCT02312687/registered?page=2