A Study of KRN23 in X-linked Hypophosphatemia
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ClinicalTrials.gov Identifier: NCT00830674 |
Recruitment Status :
Completed
First Posted : January 28, 2009
Last Update Posted : October 21, 2013
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Condition or disease | Intervention/treatment | Phase |
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X-linked Hypophosphatemia | Drug: Placebo Drug: KRN23 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: KRN23
Single IV or SC administration on day 1
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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
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Drug: Placebo
single dose IV or SC administration |
- Safety and tolerability [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ]AEs, etc
- Effect to pharmacodynamic parameter [ Time Frame: Up to 7 weeks after dosing (maximally 11 weeks) ]Change in Serum Phosphate

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830674
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 |
Principal Investigator: | Thomas O. Carpenter, M.D. | Yale University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kyowa Hakko Kirin Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00830674 |
Other Study ID Numbers: |
KRN23-US-02 |
First Posted: | January 28, 2009 Key Record Dates |
Last Update Posted: | October 21, 2013 |
Last Verified: | October 2013 |
XLH |
Familial Hypophosphatemic Rickets Hypophosphatemia 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 |