An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia

X-linked Hypophosphatemia Clinical Trial

Official title:

An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571596
• Other study ID #: KRN23-INT-002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial

2. eGFR = 60 mL/min

3. Corrected Ca < 10.8 mg/dL

4. For female of child-bearing potential, a negative serum pregnancy test

5. A willingness to utilize adequate contraception and not become pregnant [or to have their partner(s) become pregnant] during the study

6. Additional inclusion criteria apply

Exclusion Criteria:

1. Subject experienced a safety-related event in the KRN23-INT-001 study

2. Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study

3. Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study

4. Condition which could present a concern for either the subject's safety or difficulty with data interpretation

5. Additional exclusion criteria apply

Related Conditions & MeSH terms

• Familial Hypophosphatemic Rickets
• Hypophosphatemia
• X-linked Hypophosphatemia

Intervention

Drug:
• KRN23
Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.

Locations

Country	Name	City	State
Canada	Shriners Hospital for Children - Canada	Montreal	Quebec
United States	Duke Clinical Research Unit	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Clinical Research Center, Indiana University School of Medicine	Indianapolis	Indiana
United States	Yale University School of Medicine	New Haven	Connecticut
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin Pharma, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy	Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters.	13.5 months,(50 visits)
Primary	Safety and Efficacy of Repeated SC Injections of KRN23.	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.	13.5 months,(50 visits)
Secondary	Evaluation of Effect of Repeated SC Injections of KRN23	Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters (serum phosphorus)	13.5 months, (50 visits)

External Links

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