Clinical trial NCT01571596: An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia
Official title: An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: X-linked Hypophosphatemia
Keywords: XLH
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Hakko Kirin Pharma, Inc.
First posted: 2012-04-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Safety and Efficacy of Repeated SC Injections of KRN23.
timeFrame: 13.5 months,(50 visits)
Secondary outcomes:
measure: Evaluation of Effect of Repeated SC Injections of KRN23
timeFrame: 13.5 months, (50 visits)
Other outcomes:
measure: Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy
timeFrame: 13.5 months,(50 visits)
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Indianapolis
country: United States
facility: Clinical Research Center, Indiana University School of Medicine
state: Indiana
city: Durham
country: United States
facility: Duke Clinical Research Unit
state: North Carolina
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Montreal
country: Canada
facility: Shriners Hospital for Children - Canada
state: Quebec
Study officials:
affiliation: Kyowa Hakko Kirin Pharma, Inc.
name: Amy Zhang, PhD
role: STUDY_DIRECTOR
References:
citation: Imel EA, Zhang X, Ruppe MD, Weber TJ, Klausner MA, Ito T, Vergeire M, Humphrey JS, Glorieux FH, Portale AA, Insogna K, Peacock M, Carpenter TO. Prolonged Correction of Serum Phosphorus in Adults With X-Linked Hypophosphatemia Using Monthly Doses of KRN23. J Clin Endocrinol Metab. 2015 Jul;100(7):2565-73. doi: 10.1210/jc.2015-1551. Epub 2015 Apr 28.