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 Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )
ClinicalTrials.gov Identifier:
NCT00830674
First received: January 27, 2009
Last updated: October 18, 2013
Last verified: October 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
hereditary hypophosphatemic rickets
Genetic and Rare Diseases Information Center resources:
X-linked Hypophosphatemia
Hypophosphatemic Rickets
Rickets
U.S. FDA Resources
Further study details as provided by Kyowa Kirin Pharmaceutical Development, 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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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:
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 Kirin Pharmaceutical Development, Inc.:
|
XLH |
Additional relevant MeSH terms:
|
Hypophosphatemia Familial Hypophosphatemic Rickets Phosphorus Metabolism Disorders Metabolic Diseases Rickets, Hypophosphatemic Rickets Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Hypophosphatemia, Familial Renal Tubular Transport, Inborn Errors |
Kidney Diseases Urologic Diseases Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Calcium Metabolism Disorders Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on September 30, 2016