A Study of KRN23 in X-linked Hypophosphatemia
This study has been completed.
Sponsor:
Kyowa Hakko Kirin Pharma, Inc.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00830674
First received: January 27, 2009
Last updated: October 18, 2013
Last verified: October 2013
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Purpose
The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.
| Condition | Intervention | Phase |
|---|---|---|
|
X-linked Hypophosphatemia |
Drug: Placebo Drug: KRN23 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia |
Resource links provided by NLM:
Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ] [ Designated as safety issue: Yes ]AEs, etc
Secondary Outcome Measures:
- Effect to pharmacodynamic parameter [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ] [ Designated as safety issue: No ]Change in Serum Phosphate
| Enrollment: | 42 |
| Study Start Date: | December 2008 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: KRN23
Single IV or SC administration on day 1
|
Drug: KRN23
Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg
|
|
Placebo Comparator: Placebo
Single IV or SC administration on day 1
|
Drug: Placebo
single dose IV or SC administration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years or older
- Clinical diagnosis of XLH
- TmP/GFR is less than 2.0 mg/dL
- GFR is 60 mL/min or above
Exclusion Criteria:
- Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening
- History of known immunodeficiency
- Lactating females, female patients who are pregnant or planning to become pregnant during the study
- Use of a pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10 days prior to screening and dosing
- Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing
- Receipt of live (attenuated) vaccine within 3-months prior to screening
- Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830674
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830674
Locations
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Indiana | |
| General Clinical Research Center, Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202-5250 | |
| United States, North Carolina | |
| Duke Clinical Research Unit | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Investigators
| Principal Investigator: | Thomas O. Carpenter, M.D. | Yale University |
More Information
Additional Information:
No publications provided by Kyowa Hakko Kirin Pharma, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kyowa Hakko Kirin Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT00830674 History of Changes |
| Other Study ID Numbers: | KRN23-US-02 |
| Study First Received: | January 27, 2009 |
| Last Updated: | October 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
|
XLH |
Additional relevant MeSH terms:
|
Familial Hypophosphatemic Rickets Hypophosphatemia Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Deficiency Diseases Genetic Diseases, Inborn Hypophosphatemia, Familial Kidney Diseases Malnutrition |
Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutrition Disorders Phosphorus Metabolism Disorders Renal Tubular Transport, Inborn Errors Rickets Rickets, Hypophosphatemic Urologic Diseases Vitamin D Deficiency |
ClinicalTrials.gov processed this record on March 03, 2015