Status:
COMPLETED
Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)
Lead Sponsor:
Kyowa Kirin, Inc.
Collaborating Sponsors:
Kyowa Kirin Co., Ltd.
Conditions:
X-Linked Hypophosphatemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The primary objectives of this study are to: * Assess the long-term safety of KRN23 subcutaneous (SC) administration in adult subjects with XLH * Assess the proportion of subjects achieving serum pho...
Eligibility Criteria
Inclusion
- Have participated in Kyowa Hakko Kirin Pharma, Inc.'s KRN23-INT-001 (NCT01340482) or KRN23-INT-002 (NCT01571596) studies (received at least 2 doses of KRN23)
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min or eGFR of 45 to \< 60 mL/min at Screening with confirmation that the renal insufficiency was not due to nephrocalcinosis.
- Sexually active subjects must be willing to use an acceptable method of contraception (e.g., double barrier method) while participating in the study and for 30 days after receiving the last dose of KRN23.
Exclusion
- Subject experienced a safety-related event in the KRN23-INT-001 or KRN23-INT-002 study that, in the opinion of the investigator and sponsor, precludes resuming KRN23 treatment.
- Presence of nephrocalcinosis on renal ultrasound that, in the opinion of the investigator and sponsor, precludes resuming KRN23 treatment.
- Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
- Participation in an investigational drug or device trial within 30 days of enrollment (other than KRN23-INT-001 or KRN23-INT-002).
- Use of a pharmacologic vitamin D metabolite or analog (e.g., calcitriol, doxercalciferol, and paricalcitol), phosphate, or aluminum hydroxide antacids (e.g., Maalox® and Mylanta®) within 21 days prior to Screening or during the study.
- Use of medication to suppress parathyroid hormone (PTH) (e.g., Sensipar®, cinacalcet, calcimimetics) within 2 months prior to Screening.
Key Trial Info
Start Date :
January 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02312687
Start Date
January 30 2015
End Date
November 30 2018
Last Update
May 6 2024
Active Locations (5)
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1
University California San Francisco Hospital
San Francisco, California, United States, 94143
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
3
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
4
Duke University
Durham, North Carolina, United States, 27710