Trial · NCT01340482

A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia

NCT01340482, Phase 1, Phase 2, Completed, Kyowa Kirin Co., Ltd.; results first posted 2020-10-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia. Trials, record NCT01340482. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01340482

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
NCT number: NCT01340482
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 29 participants, actual
Lead sponsor: Kyowa Kirin Co., Ltd.
Conditions: X-linked Hypophosphatemia
Interventions: KRN23
First posted: 2011-04-22
Last updated: 2024-06-18
Results first posted: 2020-10-26
Limitations and caveats: Only 2 subjects were randomized in and completed the bone substudy. Subsequently, the Sponsor terminated the bone substudy due to slow accrual.

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	On-Treatment: 6.5 months, 27 total 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	On-Treatment: 6.5 months, 27 total visits	Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters including serum phosphorus, sex hormone, bone biomarkers, quality of life assessments and population pharmacokinetics of KRN23 dose levels from cumulative dosing. Summary of serum phosphorus by visit/day is captured below.
Other	Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy	On-Treatment: 6.5 months, 27 total visits	Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density and bone quality.

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	On-Treatment: 6.5 months, 27 total visits		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Evaluation of Effect of Repeated SC Injections of KRN23	On-Treatment: 6.5 months, 27 total 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	On-Treatment: 6.5 months, 27 total visits	Subjects randomized to the bone density substudy	units on a scale	NUMBER

Source ClinicalTrials.gov

Results by group43

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Safety and Efficacy of Repeated SC Injections of KRN23	KRN23	Subjects reporting at least one TEAE	24	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	Bone Substudy KRN23	Subjects reporting at least one TEAE	1	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	Bone Substudy Placebo	Subjects reporting at least one TEAE	1	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	KRN23	Subjects who died	0	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	Bone Substudy KRN23	Subjects who died	0	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	Bone Substudy Placebo	Subjects who died	0	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	KRN23	Subjects reporting SAE other than death	0	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	Bone Substudy KRN23	Subjects reporting SAE other than death	0	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	Bone Substudy Placebo	Subjects reporting SAE other than death	0	Participants
Safety and Efficacy of Repeated SC Injections of KRN23	KRN23	Subjects reporting at least one DLT	0	Participants

1 to 10 of 43Source ClinicalTrials.gov

See all 43 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	KRN23	27
Overall Study	STARTED	Bone Substudy KRN23	1
Overall Study	STARTED	Bone Substudy Placebo	1
Overall Study	COMPLETED	KRN23	25
Overall Study	COMPLETED	Bone Substudy KRN23	1
Overall Study	COMPLETED	Bone Substudy Placebo	1
Overall Study	NOT COMPLETED	KRN23	2
Overall Study	NOT COMPLETED	Bone Substudy KRN23	0
Overall Study	NOT COMPLETED	Bone Substudy Placebo	0

Source ClinicalTrials.gov

Adverse events261

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	KRN23	1	27	1
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Bone Substudy KRN23	0	1	0
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Bone Substudy Placebo	0	1	0
other	Ear pain	Ear and labyrinth disorders	KRN23	0	27	0
other	Ear pain	Ear and labyrinth disorders	Bone Substudy KRN23	1	1	1
other	Ear pain	Ear and labyrinth disorders	Bone Substudy Placebo	0	1	0
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	KRN23	1	27	2
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Bone Substudy KRN23	0	1	0
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Bone Substudy Placebo	0	1	0
other	Abdominal pain upper	Gastrointestinal disorders	KRN23	2	27	2

1 to 10 of 261Source ClinicalTrials.gov

See all 261 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	KRN23	0	27
Total, all-cause mortality	Bone Substudy KRN23	0	1
Total, all-cause mortality	Bone Substudy Placebo	0	1
Total, other adverse events	KRN23	24	27
Total, other adverse events	Bone Substudy KRN23	1	1
Total, other adverse events	Bone Substudy Placebo	1	1
Total, serious adverse events	KRN23	0	27
Total, serious adverse events	Bone Substudy KRN23	0	1
Total, serious adverse events	Bone Substudy Placebo	0	1

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25919461	DERIVED	PubMed
26073451	DERIVED	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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