An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
This study is currently recruiting participants.
Verified January 2013 by Kyowa Hakko Kirin Pharma, Inc.
Sponsor:
Kyowa Hakko Kirin Pharma, Inc.
Collaborator:
Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01571596
First received: February 23, 2012
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
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, bone quality and histomorphometric parameters.
| Condition | Intervention | Phase |
|---|---|---|
|
X-linked Hypophosphatemia |
Drug: Biological KRN23 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:
Primary Outcome Measures:
- Safety and efficacy of repeated SC injections of KRN23. [ Time Frame: 12 months,(49 visits) ] [ Designated as safety issue: Yes ]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 [ Time Frame: 12 months, (49 visits) ] [ Designated as safety issue: No ]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.
Other Outcome Measures:
- Evaluation of effect of repeated SC injections of KRN23 in Bone Substudy [ Time Frame: 12 months,(49 visits) ] [ Designated as safety issue: No ]Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters.
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Open-Label KRN23; Single-blind KRN23 vs Placebo |
Drug: Biological KRN23
Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 4 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571596
Contacts
| Contact: Amy Zhang, PhD | 609-919-1100 | azhang@kyowa-kirin-pharma.com |
Locations
| United States, California | |
| University of California San Francisco | Active, not recruiting |
| San Francisco, California, United States, 94143 | |
| United States, Connecticut | |
| Yale University School of Medicine | Active, not recruiting |
| New Haven, Connecticut, United States, 06520 | |
| United States, Indiana | |
| Clinical Research Center, Indiana University School of Medicine | Active, not recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, North Carolina | |
| Duke Clinical Research Unit | Active, not recruiting |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| University of Texas Health Science Center at Houston | Active, not recruiting |
| Houston, Texas, United States, 77030 | |
| Canada, Quebec | |
| Shriners Hospital for Children - Canada | Recruiting |
| Montreal, Quebec, Canada, H3G 1A6 | |
| Contact: Michaela Durigova, PhD 514-282-7158 mdurigova@shriners.mcgill.ca | |
| Principal Investigator: Francis H Glorieux, M.D. | |
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Company, Limited
More Information
Additional Information:
No publications provided
| Responsible Party: | Kyowa Hakko Kirin Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT01571596 History of Changes |
| Other Study ID Numbers: | KRN23-INT-002 |
| Study First Received: | February 23, 2012 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
|
XLH |
Additional relevant MeSH terms:
|
Hypophosphatemia Hypophosphatemic Rickets, X-Linked Dominant Phosphorus Metabolism Disorders Metabolic Diseases Rickets Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Hypophosphatemia, Familial Renal Tubular Transport, Inborn Errors Kidney Diseases |
Urologic Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Calcium Metabolism Disorders Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on May 21, 2013