A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
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ClinicalTrials.gov Identifier: NCT01340482 |
Recruitment Status
:
Completed
First Posted
: April 22, 2011
Last Update Posted
: June 14, 2016
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Condition or disease | Intervention/treatment | Phase |
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X-linked Hypophosphatemia | Drug: KRN23 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
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 : | April 2011 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | October 2013 |

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)
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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.
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- Safety and Efficacy of repeated SC injections of KRN23 [ Time Frame: 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.
- Evaluation of effect of repeated SC injections of KRN23 [ Time Frame: 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.
- Evaluation of effect of repeated SC injections of KRN23 in Bone Substudy [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

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): NCT01340482
United States, California | |
University of California, San Francisco Medical Center | |
San Francisco, California, United States, 94143 | |
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520 | |
United States, Indiana | |
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 | |
Canada, Quebec | |
Shriners Hospital for Children - Canada | |
Montreal, Quebec, Canada, H3G 1A6 |
Study Director: | Amy Zhang, PhD | Kyowa Hakko Kirin Pharma, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kyowa Hakko Kirin Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT01340482 History of Changes |
Other Study ID Numbers: |
KRN23-INT-001 |
First Posted: | April 22, 2011 Key Record Dates |
Last Update Posted: | June 14, 2016 |
Last Verified: | January 2015 |
Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, 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 |