A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
Sponsor
Kyowa Hakko Kirin Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01340482
Collaborator
Kyowa Kirin Co., Ltd. (Industry)
29
6
1
30
4.8
0.2
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). A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone mineral density and bone quality.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II, Open-Label, Repeat-Dose, Dose-Escalation Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia
Study Start Date
:
Apr 1, 2011
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
Oct 1, 2013
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 4 doses) |
Drug: KRN23
Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Main Inclusion Criteria:
-
18 years or older
-
Clinical diagnosis of XLH
-
TmP/GFR < 2.0 mg/dL
-
GFR ≥60 mL/min
-
Corrected Ca <10.8 mg/dL
-
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
Main Exclusion Criteria:
-
Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within 3-weeks of Screening
-
History of known immunodeficiency
-
Pregnant or lactating females subjects or female planning to be become pregnant during the study
-
Receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months of Screening, and/or during the study
-
Use of pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10-days prior to Screening and/or dosing
-
Use of any supplement containing phosphate, calcium and/or vitamin D within 10-days prior to Screening and/or dosing
-
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 Medical Center | 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 | 46202-5250 |
| 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:
NCT01340482
Other Study ID Numbers:
- KRN23-INT-001
First Posted:
Apr 22, 2011
Last Update Posted:
Oct 26, 2020
Last Verified:
Sep 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 4 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor. | ||
| Period Title: Overall Study | |||
| STARTED | 27 | 1 | 1 |
| COMPLETED | 25 | 1 | 1 |
| NOT COMPLETED | 2 | 0 | 0 |
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 4 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor. | Total of all reporting groups | ||
| Overall Participants | 27 | 1 | 1 | 29 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
26
96.3%
|
1
100%
|
1
100%
|
28
96.6%
|
| >=65 years |
1
3.7%
|
0
0%
|
0
0%
|
1
3.4%
|
| Age (years) [Median (Full Range) ] | ||||
| Median (Full Range) [years] |
42
|
21
|
28
|
41
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
18
66.7%
|
1
100%
|
1
100%
|
20
69%
|
| Male |
9
33.3%
|
0
0%
|
0
0%
|
9
31%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White/Caucasian |
26
96.3%
|
1
100%
|
1
100%
|
28
96.6%
|
| Black/African American/African Caribbean |
1
3.7%
|
0
0%
|
0
0%
|
1
3.4%
|
| Region of Enrollment (participants) [Number] | ||||
| Canada |
0
0%
|
1
100%
|
1
100%
|
2
6.9%
|
| United States |
27
100%
|
0
0%
|
0
0%
|
27
93.1%
|
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 | On-Treatment: 6.5 months, 27 total 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 4 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor. | ||
| Measure Participants | 27 | 1 | 1 |
| Subjects reporting at least one TEAE |
24
88.9%
|
1
100%
|
1
100%
|
| Subjects who died |
0
0%
|
0
0%
|
0
0%
|
| Subjects reporting SAE other than death |
0
0%
|
0
0%
|
0
0%
|
| Subjects reporting at least one DLT |
0
0%
|
0
0%
|
0
0%
|
| Subjects reporting AE leading to discontinuation |
1
3.7%
|
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 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. |
| Time Frame | On-Treatment: 6.5 months, 27 total 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 4 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor. |
| Measure Participants | 26 |
| Visit 2 (D0)/0 |
1.89
|
| Visit 3 (D3)/3 |
2.18
|
| Visit 4 (D7)/7 |
2.20
|
| Visit 5 (D12)/12 |
2.14
|
| Visit 6 (D18)/18 |
2.15
|
| Visit 7 (D26)/26 |
1.96
|
| Visit 8 (D28)/0 |
1.93
|
| Visit 9 (D31)/3 |
2.35
|
| Visit 10 (D35)/7 |
2.45
|
| Visit 11 (D40)/12 |
2.31
|
| Visit 12 (D46)/18 |
2.28
|
| Visit 13 (D54)/26 |
2.15
|
| Visit 14 (D56)/0 |
2.12
|
| Visit 15 (D59)/3 |
2.57
|
| Visit 16 (D63)/7 |
2.85
|
| Visit 17 (D68)/12 |
2.83
|
| Visit 18 (D74)/18 |
2.60
|
| Visit 19 (D82)/26 |
2.33
|
| Visit 20 (D84)/0 |
2.26
|
| Visit 21 (D87)/3 |
2.64
|
| Visit 22 (D91)/7 |
3.03
|
| Visit 23 (D96)/12 |
2.94
|
| Visit 24 (D102)/18 |
2.82
|
| Visit 25 (D110)/26 |
2.54
|
| End of Study - Visit 26 (D120) |
2.22
|
| Early Withdrawal |
1.30
|
| 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 and bone quality. |
| Time Frame | On-Treatment: 6.5 months, 27 total visits |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects randomized to the bone density substudy |
| 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 | Subjects were monitored for any untoward medical occurrences from the time of signed ICF through 30 days postdose. | |||||
|---|---|---|---|---|---|---|
| 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 4 doses) KRN23: Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the 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 | 0/27 (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 | 0/27 (0%) | 0/1 (0%) | 0/1 (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 | 24/27 (88.9%) | 1/1 (100%) | 1/1 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Iron deficiency anaemia | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| Ear pain | 0/27 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Gastrooesophageal reflux disease | 1/27 (3.7%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Abdominal pain upper | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Dyspepsia | 2/27 (7.4%) | 4 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Constipation | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Diarrhoea | 5/27 (18.5%) | 6 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Nausea | 2/27 (7.4%) | 5 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Mouth ulceration | 0/27 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Toothache | 1/27 (3.7%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Sensitivity of teeth | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Lip ulceration | 0/27 (0%) | 0 | 1/1 (100%) | 3 | 0/1 (0%) | 0 |
| General disorders | ||||||
| Vessel puncture site haematoma | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Feeling hot | 1/27 (3.7%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Fatigue | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Feeling cold | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Pain | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Malaise | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Local swelling | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Oedema peripheral | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Pyrexia | 0/27 (0%) | 0 | 0/1 (0%) | 0 | 1/1 (100%) | 1 |
| Injection site urticaria | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Injection site erythema | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Injection site reaction | 1/27 (3.7%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Injection site pain | 0/27 (0%) | 0 | 1/1 (100%) | 2 | 0/1 (0%) | 0 |
| Influenza like illness | 0/27 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Infections and infestations | ||||||
| Influenza | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 1/1 (100%) | 1 |
| Ear infection | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Bronchitis | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Gastroenteritis viral | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Laryngitis | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Urinary tract infection | 2/27 (7.4%) | 2 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Upper respiratory tract infection | 4/27 (14.8%) | 4 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Tooth infection | 3/27 (11.1%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Viral infection | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Sinusitis | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Post procedural infection | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Oral herpes | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Nasopharyngitis | 7/27 (25.9%) | 8 | 1/1 (100%) | 2 | 1/1 (100%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Procedural pain | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Post-traumatic pain | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Injury | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Fall | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Contusion | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Arthropod bite | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Investigations | ||||||
| Neutrophil count decreased | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Blood triglycerides increased | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Blood creatine phosphokinase increased | 1/27 (3.7%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Pain in extremity | 3/27 (11.1%) | 6 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Neck pain | 2/27 (7.4%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Myalgia | 2/27 (7.4%) | 2 | 1/1 (100%) | 2 | 0/1 (0%) | 0 |
| Musculoskeletal pain | 3/27 (11.1%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Musculoskeletal chest pain | 1/27 (3.7%) | 1 | 1/1 (100%) | 3 | 0/1 (0%) | 0 |
| Muscle spasms | 1/27 (3.7%) | 1 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Musculoskeletal stiffness | 1/27 (3.7%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Ligament pain | 0/27 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Joint swelling | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Spinal column stenosis | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Flank pain | 2/27 (7.4%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Exostosis | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Back pain | 4/27 (14.8%) | 5 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Arthritis | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Arthralgia | 6/27 (22.2%) | 7 | 1/1 (100%) | 7 | 0/1 (0%) | 0 |
| Nervous system disorders | ||||||
| Visual field defect | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Restless legs syndrome | 5/27 (18.5%) | 5 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Presyncope | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Migraine | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 1/1 (100%) | 5 |
| Memory impairment | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Headache | 3/27 (11.1%) | 4 | 1/1 (100%) | 4 | 1/1 (100%) | 2 |
| Dizziness | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Disturbance in attention | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Burning sensation | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||
| Pregnancy | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Psychiatric disorders | ||||||
| Anxiety | 2/27 (7.4%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Polyuria | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Pollakiuria | 2/27 (7.4%) | 3 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Wheezing | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Tonsillar hypertrophy | 0/27 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Sinus disorder | 1/27 (3.7%) | 2 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Pleurisy | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Painful respiration | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Oropharyngeal pain | 0/27 (0%) | 0 | 1/1 (100%) | 1 | 0/1 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Swelling face | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Dry skin | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Cold sweat | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Alopecia | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 1/27 (3.7%) | 1 | 0/1 (0%) | 0 | 0/1 (0%) | 0 |
Limitations/Caveats
Only 2 subjects were randomized in and completed the bone substudy. Subsequently, the Sponsor terminated the bone substudy due to slow accrual.
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:
NCT01340482
Other Study ID Numbers:
- KRN23-INT-001
First Posted:
Apr 22, 2011
Last Update Posted:
Oct 26, 2020
Last Verified:
Sep 1, 2020