A Study of KRN23 in X-linked Hypophosphatemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

NCT02526160

X-linked Hypophosphatemia

COMPLETED PHASE3

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

NCT04842019

X-linked Hypophosphatemia (XLH)

COMPLETED PHASE4

Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)

NCT02163577

X-linked Hypophosphatemia

COMPLETED PHASE2

Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH

NCT03920072

X-linked Hypophosphatemia

COMPLETED PHASE3

A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants

NCT06137482

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

X-linked Hypophosphatemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

KRN23

Single IV or SC administration on day 1

Group Type EXPERIMENTAL

KRN23

Intervention Type DRUG

Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg

Placebo

Single IV or SC administration on day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single dose IV or SC administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

single dose IV or SC administration

Intervention Type DRUG

KRN23

Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18 years or older
2. Clinical diagnosis of XLH
3. TmP/GFR is less than 2.0 mg/dL
4. GFR is 60 mL/min or above

Exclusion Criteria

1. Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening
2. History of known immunodeficiency
3. Lactating females, female patients who are pregnant or planning to become pregnant during the study
4. Use of a pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10 days prior to screening and dosing
5. Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing
6. Receipt of live (attenuated) vaccine within 3-months prior to screening
7. Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No