Trial · NCT01571596
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
NCT01571596, Phase 1, Phase 2, Completed, Kyowa Kirin Co., Ltd.; results first posted 2021-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia. Trials, record NCT01571596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01571596
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
- NCT number
- NCT01571596
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Conditions
- X-linked Hypophosphatemia
- Interventions
- KRN23
- First posted
- 2012-04-05
- Last updated
- 2024-06-18
- Results first posted
- 2021-02-17
- Limitations and caveats
- Due to the lack of enrollment, the bone substudy was terminated early.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Efficacy of Repeated SC Injections of KRN23. | 13.5 months,(50 visits) | Safety and efficacy of repeated SC injections of KRN23, from Baseline, as assessed by serum phosphorus levels, immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing. |
| Secondary | Evaluation of Effect of Repeated SC Injections of KRN23 | 13.5 months, (50 visits) | Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters (serum phosphorus) |
| Other | Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy | 13.5 months,(50 visits) | Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Efficacy of Repeated SC Injections of KRN23. | 13.5 months,(50 visits) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Evaluation of Effect of Repeated SC Injections of KRN23 | 13.5 months, (50 visits) | Efficacy analysis set: All subjects who received at least 1 dose of KRN23 and completed at least one 28-day post-dose evaluation. | mg/dL | MEAN |
| OTHER_PRE_SPECIFIED | Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy | 13.5 months,(50 visits) | units on a scale | NUMBER |
Source ClinicalTrials.gov
Results by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Efficacy of Repeated SC Injections of KRN23. | KRN23 | With Any TEAE | 21 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | Bone Substudy KRN23 | With Any TEAE | 1 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | Bone Substudy Placebo | With Any TEAE | 1 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | KRN23 | With Any Drug-related TEAE | 13 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | Bone Substudy KRN23 | With Any Drug-related TEAE | 1 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | Bone Substudy Placebo | With Any Drug-related TEAE | 0 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | KRN23 | With Any TEAE with an Outcome of Death | 0 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | Bone Substudy KRN23 | With Any TEAE with an Outcome of Death | 0 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | Bone Substudy Placebo | With Any TEAE with an Outcome of Death | 0 | Participants | |
| Safety and Efficacy of Repeated SC Injections of KRN23. | KRN23 | With Any Serious TEAE | 3 | Participants |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KRN23 | 21 | |
| Overall Study | STARTED | Bone Substudy KRN23 | 1 | |
| Overall Study | STARTED | Bone Substudy Placebo | 1 | |
| Overall Study | COMPLETED | KRN23 | 19 | |
| Overall Study | COMPLETED | Bone Substudy KRN23 | 0 | |
| Overall Study | COMPLETED | Bone Substudy Placebo | 0 | |
| Overall Study | NOT COMPLETED | KRN23 | 2 | |
| Overall Study | NOT COMPLETED | Bone Substudy KRN23 | 1 | |
| Overall Study | NOT COMPLETED | Bone Substudy Placebo | 1 |
Source ClinicalTrials.gov
Adverse events375
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 | BRADYCARDIA | Cardiac disorders | KRN23 | 1 | 21 | 1 |
| other | BRADYCARDIA | Cardiac disorders | Bone Substudy KRN23 | 0 | 1 | 0 |
| other | BRADYCARDIA | Cardiac disorders | Bone Substudy Placebo | 0 | 1 | 0 |
| other | PALPITATIONS | Cardiac disorders | KRN23 | 1 | 21 | 1 |
| other | PALPITATIONS | Cardiac disorders | Bone Substudy KRN23 | 0 | 1 | 0 |
| other | PALPITATIONS | Cardiac disorders | Bone Substudy Placebo | 0 | 1 | 0 |
| other | EAR PAIN | Ear and labyrinth disorders | KRN23 | 1 | 21 | 1 |
| other | EAR PAIN | Ear and labyrinth disorders | Bone Substudy KRN23 | 0 | 1 | 0 |
| other | EAR PAIN | Ear and labyrinth disorders | Bone Substudy Placebo | 0 | 1 | 0 |
| other | VERTIGO | Ear and labyrinth disorders | KRN23 | 1 | 21 | 1 |
1 to 10 of 375Source ClinicalTrials.gov
See all 375 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KRN23 | 0 | 21 |
| Total, all-cause mortality | Bone Substudy KRN23 | 0 | 1 |
| Total, all-cause mortality | Bone Substudy Placebo | 0 | 1 |
| Total, other adverse events | KRN23 | 21 | 21 |
| Total, other adverse events | Bone Substudy KRN23 | 1 | 1 |
| Total, other adverse events | Bone Substudy Placebo | 1 | 1 |
| Total, serious adverse events | KRN23 | 3 | 21 |
| Total, serious adverse events | Bone Substudy KRN23 | 0 | 1 |
| Total, serious adverse events | Bone Substudy Placebo | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25919461 | 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/NCT01571596
GET https://conductscience.org/api/trials/v1/NCT01571596/results?page=2