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Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

NCT02537431•Kyowa Kirin, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, aged 18 - 65 years, inclusive
•2. Diagnosis of XLH supported by classic clinical features of adult XLH (such as short stature or bowed legs), and at least one of the following at Screening:
•* Documented phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX) PHEX mutation in either the patient or in a directly related family member with appropriate X-linked inheritance
•* Serum intact FGF23 (iFGF23) level \> 30 pg/mL by Kainos assay
•3. Biochemical findings consistent with XLH based on overnight fasting (min. 8 hours):
•* Serum phosphorus \< 2.5 mg/dL at Screening
•* Ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate (TmP/GFR) \< 2.5 mg/dL at Screening
•4. Presence of skeletal pain attributed to XLH/osteomalacia, as defined by a score of ≥ 4 on the Brief Pain Inventory question 3 (BPI-Q3, Worst Pain) at Screening. (Skeletal pain that, in the opinion of the investigator, is attributed solely to causes other than XLH/osteomalacia-for example, back pain or joint pain in the presence of severe osteoarthritis by radiograph in that anatomical location-in the absence of any skeletal pain likely attributed to XLH/osteomalacia should not be considered for eligibility)
•5. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation) or estimated glomerular filtration rate (eGFR) eGFR of 45 to \<60 mL/min at Screening with confirmation that the renal insufficiency is not due to nephrocalcinosis
•6. Provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures. If the subject in a minor, provide written assent and have a legally authorized representative willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any research-related procedures
+4 more criteria

Exclusion Criteria

•1. Use of any pharmacologic vitamin D metabolite or analog (e.g. calcitriol, doxercalciferol, and paricalcitol) within the 2 years before Screening
•2. Use of oral phosphate within 2 years before Screening
•3. Use of aluminum hydroxide antacids, acetazolamides, and thiazides within 7 days prior to Screening
•4. Use of bisphosphonates in the 2 years prior to Screening
•5. Use of denosumab in the 6 months prior to Screening
•6. Use of teriparatide in the 2 months prior to Screening
•7. Chronic use of systemic corticosteroids defined as more than 10 days in the 2 months prior to Screening
•8. Corrected serum calcium level ≥ 10.8 mg/dL (2.7 mmol/L) at Screening
•9. Serum intact parathyroid hormone (iPTH) ≥ 2.5 times the upper limit of normal (ULN) at Screening
•10. Use of medication to suppress parathyroid hormone (PTH) (cinacalcet for example) within 60 days prior to Screening
+15 more criteria

Locations (14)

UCSF Medical Center at Mission

San Francisco, California, United States

Yale University School of Medicine - Yale New-Haven Hospital/Yale Center for Clinical Investigation

New Haven, Connecticut, United States

Indiana University Department of Medicine University Hospital

Indianapolis, Indiana, United States

Duke University Medical Center

Durham, North Carolina, United States

Houston Methodist Hospital

Houston, Texas, United States

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Shriners Hospital for Children

Montreal, Quebec, Canada

Aarhus University Hospital-Dept of Endocrinology and Internal Medicine

Aarhus, Denmark

CHU de Bicêtre, Service d'Endocrinologie et des Maladies de la Reproduction

Le Kremlin-Bicêtre, France

CHU Paris Centre - Hôpital Cochin

Paris, France

Key Dates

Start Date

December 23, 2015

Primary Completion Date

August 30, 2017

Completion Date

December 13, 2018

Last Updated

June 18, 2024

Enrollment

ACTUAL participants

Conditions

X-linked Hypophosphatemia

Interventions

burosumab

BIOLOGICAL

Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners

NCT03745521

X-Linked Hypophosphatemia

View study

AVAILABLE

Expanded Access to Burosumab

NCT03775187

X-linked HypophosphatemiaTumor-Induced Osteomalacia

View study

COMPLETEDPHASE4

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

Inclusion Criteria

Exclusion Criteria

Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners

Expanded Access to Burosumab

Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH

Foot Disorders in X-linked Hypophosphatemia

Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia : a RCT