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NCT Number: NCT01571596

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

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).

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Key information

Conditions

X-linked Hypophosphatemia Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Familial Hypophosphatemic Rickets Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hypophosphatemia Hypophosphatemia, Familial Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders Renal Tubular Transport, Inborn Errors Rickets Rickets, Hypophosphatemic Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shriners Hospital for Children - Canada, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial
  • eGFR ≥ 60 mL/min
  • Corrected Ca < 10.8 mg/dL
  • For female of child-bearing potential, a negative serum pregnancy test
  • 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

Exclusion criteria

  • Subject experienced a safety-related event in the KRN23-INT-001 study
  • Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study
  • Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study
  • Condition which could present a concern for either the subject's safety or difficulty with data interpretation
  • Additional exclusion criteria apply

Treatment and study plan

KRN23

Drug

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.

Primary outcomes

  1. Safety and Efficacy of Repeated SC Injections of KRN23.

    Time frame: 13.5 months,(50 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.

Secondary outcomes

  1. Evaluation of Effect of Repeated SC Injections of KRN23

    Time frame: 13.5 months, (50 visits)

    Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters (serum phosphorus)

Other outcomes

  1. Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy

    Time frame: 13.5 months,(50 visits)

    Evaluation of effect of repeated SC injections of KRN23, compared to Placebo on bone mineral density, bone quality and histomorphometric parameters.

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 5, 2012
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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