A Study of KRN23 in X-linked Hypophosphatemia

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: X-linked Hypophosphatemia

Treatments: Drug: KRN23; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830674

KRN23-US-02

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

KRN23

Experimental group

Description:

Single IV or SC administration on day 1

Treatment:

Drug: KRN23

Placebo

Placebo Comparator group

Description:

Single IV or SC administration on day 1

Treatment:

Drug: Placebo