An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
Sponsor
Kyowa Hakko Kirin Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01571596
Collaborator
Kyowa Kirin Co., Ltd. (Industry)
23
6
1
28
3.8
0.1
Study Details
Study Description
Brief Summary
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia
Study Start Date
:
Feb 1, 2012
Actual Primary Completion Date
:
Sep 1, 2013
Actual Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KRN23 Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses) |
Drug: KRN23
Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial
-
eGFR ≥ 60 mL/min
-
Corrected Ca < 10.8 mg/dL
-
For female of child-bearing potential, a negative serum pregnancy test
-
A willingness to utilize adequate contraception and not become pregnant [or to have their partner(s) become pregnant] during the study
-
Additional inclusion criteria apply
Exclusion Criteria:
-
Subject experienced a safety-related event in the KRN23-INT-001 study
-
Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study
-
Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study
-
Condition which could present a concern for either the subject's safety or difficulty with data interpretation
-
Additional exclusion criteria apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California San Francisco | San Francisco | California | United States | 94143 |
| 2 | Yale University School of Medicine | New Haven | Connecticut | United States | 06520 |
| 3 | Clinical Research Center, Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 4 | Duke Clinical Research Unit | Durham | North Carolina | United States | 27710 |
| 5 | University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
| 6 | Shriners Hospital for Children - Canada | Montreal | Quebec | Canada | H3G 1A6 |
Sponsors and Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Kyowa Kirin Co., Ltd.
Investigators
- Study Director: Amy Zhang, PhD, Kyowa Hakko Kirin Pharma, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01571596
Other Study ID Numbers:
- KRN23-INT-002
First Posted:
Apr 5, 2012
Last Update Posted:
Feb 17, 2021
Last Verified:
Oct 1, 2020
Keywords provided by Kyowa Hakko Kirin Pharma, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | KRN23 | Bone Substudy KRN23 | Bone Substudy Placebo |
|---|---|---|---|
| Arm/Group Description | Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor. | A Bone substudy in eligible subjects will evaluate the effects of KRN23 on various bone parameters. Subjects will undergo clinical assessments, inclusive of DXA and pQCT at Visits 17 and 33 (prior to dosing), and the end-of-study visit, Visit 49. A subset of subjects will have a bone biopsy of the iliac crest at Visit 33. | A Bone substudy in eligible subjects will evaluate the effects of KRN23 on various bone parameters. Subjects will undergo clinical assessments, inclusive of DXA and pQCT at Visits 17 and 33 (prior to dosing), and the end-of-study visit, Visit 49. A subset of subjects will have a bone biopsy of the iliac crest at Visit 33. |
| Period Title: Overall Study | |||
| STARTED | 21 | 1 | 1 |
| COMPLETED | 19 | 0 | 0 |
| NOT COMPLETED | 2 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | KRN23 | Bone Substudy KRN23 | Bone Substudy Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor. | Total of all reporting groups | ||
| Overall Participants | 21 | 1 | 1 | 23 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
20
95.2%
|
1
100%
|
1
100%
|
22
95.7%
|
| >=65 years |
1
4.8%
|
0
0%
|
0
0%
|
1
4.3%
|
| Age (years) [Mean (Full Range) ] | ||||
| Mean (Full Range) [years] |
43.0
|
22
|
28
|
41.1
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
12
57.1%
|
1
100%
|
1
100%
|
14
60.9%
|
| Male |
9
42.9%
|
0
0%
|
0
0%
|
9
39.1%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White/Caucasian |
20
95.2%
|
1
100%
|
1
100%
|
22
95.7%
|
| Black/African American/African Caribbean |
1
4.8%
|
0
0%
|
0
0%
|
1
4.3%
|
| Region of Enrollment (participants) [Number] | ||||
| Canada |
0
0%
|
1
100%
|
1
100%
|
2
8.7%
|
| United States |
21
100%
|
0
0%
|
0
0%
|
21
91.3%
|
Outcome Measures
| Title | Safety and Efficacy of Repeated SC Injections of KRN23. |
|---|---|
| Description | 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. |
| Time Frame | 13.5 months,(50 visits) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KRN23 | Bone Substudy KRN23 | Bone Substudy Placebo |
|---|---|---|---|
| Arm/Group Description | Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor. | ||
| Measure Participants | 21 | 1 | 1 |
| With Any TEAE |
21
100%
|
1
100%
|
1
100%
|
| With Any Drug-related TEAE |
13
61.9%
|
1
100%
|
0
0%
|
| With Any TEAE with an Outcome of Death |
0
0%
|
0
0%
|
0
0%
|
| With Any Serious TEAE |
3
14.3%
|
0
0%
|
0
0%
|
| With Any Drug-related Serious TEAE |
0
0%
|
0
0%
|
0
0%
|
| With Any Serious TEAE with an Outcome of Death |
0
0%
|
0
0%
|
0
0%
|
| Title | Evaluation of Effect of Repeated SC Injections of KRN23 |
|---|---|
| Description | Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters (serum phosphorus) |
| Time Frame | 13.5 months, (50 visits) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set: All subjects who received at least 1 dose of KRN23 and completed at least one 28-day post-dose evaluation. |
| Arm/Group Title | KRN23 |
|---|---|
| Arm/Group Description | Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor. |
| Measure Participants | 22 |
| Baseline |
1.85
|
| Ext Visit 1 /0 |
1.88
|
| Ext Visit 2 /7 |
2.86
|
| Ext Visit 3 /14 |
2.87
|
| Ext Visit 4 /25 |
2.48
|
| Ext Visit 5 /0 |
2.25
|
| Ext Visit 6 /7 |
2.91
|
| Ext Visit 7 /14 |
2.95
|
| Ext Visit 8 /25 |
2.67
|
| Ext Visit 9 /0 |
2.43
|
| Ext Visit 10 /7 |
2.96
|
| Ext Visit 11 /14 |
2.84
|
| Ext Visit 12 /25 |
2.59
|
| Ext Visit 13 /0 |
2.42
|
| Ext Visit 14 /7 |
2.92
|
| Ext Visit 15 /14 |
2.90
|
| Ext Visit 16 /25 |
2.57
|
| Ext Visit 17 /0 |
2.35
|
| Ext Visit 18 /7 |
2.82
|
| Ext Visit 19 /14 |
2.74
|
| Ext Visit 20 /25 |
2.60
|
| Ext Visit 21 /0 |
2.35
|
| Ext Visit 22 /7 |
2.94
|
| Ext Visit 23 /14 |
2.93
|
| Ext Visit 24 /25 |
2.60
|
| Ext Visit 25 /0 |
2.37
|
| Ext Visit 26 /7 |
2.83
|
| Ext Visit 27 /14 |
2.79
|
| Ext Visit 28 /25 |
2.59
|
| Ext Visit 29 /0 |
2.41
|
| Ext Visit 30 /7 |
2.87
|
| Ext Visit 31 /14 |
2.81
|
| Ext Visit 32 /25 |
2.55
|
| Ext Visit 33 /0 |
2.42
|
| Ext Visit 34 /7 |
2.79
|
| Ext Visit 35 /14 |
2.75
|
| Ext Visit 36 /25 |
2.53
|
| Ext Visit 37 /0 |
2.52
|
| Ext Visit 38 /7 |
2.85
|
| Ext Visit 39 /14 |
2.69
|
| Ext Visit 40 /25 |
2.48
|
| Ext Visit 41 /0 |
2.29
|
| Ext Visit 42 /7 |
2.71
|
| Ext Visit 43 /14 |
2.70
|
| Ext Visit 44 /25 |
2.43
|
| Ext Visit 45 /0 |
2.25
|
| Ext Visit 46 /7 |
2.73
|
| Ext Visit 47 /14 |
2.61
|
| Ext Visit 48 /25 |
2.43
|
| Ext Visit 49 /38 |
2.07
|
| Ext Visit 50 /81 |
1.78
|
| Title | Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy |
|---|---|
| Description | Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters. |
| Time Frame | 13.5 months,(50 visits) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bone Substudy KRN23 | Bone Substudy Placebo |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 1 | 1 |
| Number [units on a scale] |
NA
|
NA
|
Adverse Events
| Time Frame | After the first dose of study drug in study through the end of study, up to 13.5 months | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | KRN23 | Bone Substudy KRN23 | Bone Substudy Placebo | |||
| Arm/Group Description | Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor. | |||||
All Cause Mortality |
||||||
| KRN23 | Bone Substudy KRN23 | Bone Substudy Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | 0/1 (0%) | 0/1 (0%) | |||
Serious Adverse Events |
||||||
| KRN23 | Bone Substudy KRN23 | Bone Substudy Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/21 (14.3%) | 0/1 (0%) | 0/1 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Cervical Spinal Stenosis | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Breast Cancer | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertensive crisis | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| KRN23 | Bone Substudy KRN23 | Bone Substudy Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/21 (100%) | 1/1 (100%) | 1/1 (100%) | |||
| Cardiac disorders | ||||||
| BRADYCARDIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| PALPITATIONS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| EAR PAIN | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| VERTIGO | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| DEAFNESS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HYPOACUSIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Eye disorders | ||||||
| DRY EYE | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| EYE PRURITUS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| VOMITING | 1/21 (4.8%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| GINGIVAL ULCERATION | 0/21 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 0/21 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| TOOTHACHE | 0/21 (0%) | 0 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| ABDOMINAL PAIN UPPER | 3/21 (14.3%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| LIP ULCERATION | 0/21 (0%) | 0 | 1/1 (100%) | 4 | 0/1 (0%) | 0 |
| NAUSEA | 2/21 (9.5%) | 4 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| POOR DENTAL CONDITION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| ABDOMINAL PAIN | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| LIP BLISTER | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| FOOD POISONING | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| ABDOMINAL DISCOMFORT | 4/21 (19%) | 6 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| DIARRHOEA | 3/21 (14.3%) | 5 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| IRRITABLE BOWEL SYNDROME | 1/21 (4.8%) | 10 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HAEMATOCHEZIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| General disorders | ||||||
| INJECTION SITE HAEMATOMA | 0/21 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| INFLUENZA LIKE ILLNESS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE ERYTHEMA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| FATIGUE | 3/21 (14.3%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE PAIN | 1/21 (4.8%) | 1 | 1/1 (100%) | 6 | 0/1 (0%) | 0 |
| GRAVITATIONAL OEDEMA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HYPOTHERMIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| APPLICATION SITE REACTION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| PAIN | 1/21 (4.8%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| NODULE | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE REACTION | 5/21 (23.8%) | 26 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE RASH | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| INJECTION SITE PRURITUS | 1/21 (4.8%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| HEPATIC STEATOSIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Immune system disorders | ||||||
| SEASONAL ALLERGY | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||
| VULVOVAGINAL MYCOTIC INFECTION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| VIRAL PHARYNGITIS | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| VIRAL INFECTION | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| URINARY TRACT INFECTION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| TOOTH INFECTION | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| SINUSITIS | 6/21 (28.6%) | 7 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| RESPIRATORY TRACT INFECTION VIRAL | 2/21 (9.5%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| UPPER RESPIRATORY TRACT INFECTION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| POST PROCEDURAL INFECTION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| TOOTH ABSCESS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| VAGINITIS BACTERIAL | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| PHARYNGITIS STREPTOCOCCAL | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| PHARYNGITIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| NASOPHARYNGITIS | 2/21 (9.5%) | 3 | 1/1 (100%) | 1 | 1/1 (100%) | 1 |
| LARYNGITIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| INFLUENZA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| EAR INFECTION | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| GASTROENTERITIS VIRAL | 3/21 (14.3%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| BRONCHITIS | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| GASTROENTERITIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| MUSCLE STRAIN | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HEAD INJURY | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| GINGIVAL INJURY | 0/21 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| EXCORIATION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| CONTUSION | 1/21 (4.8%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| TOOTH FRACTURE | 3/21 (14.3%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| SOFT TISSUE INJURY | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| PROCEDURAL PAIN | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| POST PROCEDURAL SWELLING | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Investigations | ||||||
| WHITE BLOOD CELL COUNT DECREASED | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| NEUTROPHIL COUNT DECREASED | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| BLOOD PRESSURE DECREASED | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 1/21 (4.8%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| ALANINE AMINOTRANSFERASE INCREASED | 1/21 (4.8%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| TENDONITIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| PAIN IN EXTREMITY | 4/21 (19%) | 4 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| MUSCULOSKELETAL PAIN | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| MUSCULOSKELETAL DISCOMFORT | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| MUSCLE SPASMS | 2/21 (9.5%) | 6 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| JOINT SWELLING | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| JOINT EFFUSION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| JOINT CREPITATION | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HAEMARTHROSIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| CERVICAL SPINAL STENOSIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| BACK PAIN | 5/21 (23.8%) | 6 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| ARTHRALGIA | 6/21 (28.6%) | 10 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Nervous system disorders | ||||||
| SYNCOPE | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| SINUS HEADACHE | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| SCIATICA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| RESTLESS LEGS SYNDROME | 3/21 (14.3%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| PARAESTHESIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| NEURITIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| MIGRAINE | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 1/1 (100%) | 2 |
| HYPOAESTHESIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HEADACHE | 2/21 (9.5%) | 2 | 1/1 (100%) | 6 | 0/1 (0%) | 0 |
| DYSKINESIA | 1/21 (4.8%) | 5 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| DIZZINESS | 4/21 (19%) | 4 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| CARPAL TUNNEL SYNDROME | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| BURNING SENSATION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Psychiatric disorders | ||||||
| INSOMNIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| DEPRESSION | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Renal and urinary disorders | ||||||
| RENAL PAIN | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| POLLAKIURIA | 2/21 (9.5%) | 5 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| NEPHROLITHIASIS | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HYPERCALCIURIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HAEMATURIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| DYSURIA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| DYSMENORRHOEA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| TONSILLAR HYPERTROPHY | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| SINUS CONGESTION | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| RESPIRATORY TRACT CONGESTION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| OROPHARYNGEAL PAIN | 0/21 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| NASAL CONGESTION | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| DYSPNOEA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| COUGH | 1/21 (4.8%) | 1 | 1/1 (100%) | 2 | 0/1 (0%) | 0 |
| ASTHMA | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| ALLERGIC RESPIRATORY SYMPTOM | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| SKIN REACTION | 1/21 (4.8%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| RASH | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| DERMATITIS CONTACT | 2/21 (9.5%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| DERMATITIS ALLERGIC | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||
| VARICOSE VEIN | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| HOT FLUSH | 1/21 (4.8%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
Limitations/Caveats
Due to the lack of enrollment, the bone substudy was terminated early.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Kyowa Kirin Pharmaceutical Development |
|---|---|
| Organization | Kyowa Kirin Pharmaceutical Development |
| Phone | 609-919-1100 |
| kkd.clintrial.82@kyowakirin.com |
Responsible Party:
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01571596
Other Study ID Numbers:
- KRN23-INT-002
First Posted:
Apr 5, 2012
Last Update Posted:
Feb 17, 2021
Last Verified:
Oct 1, 2020