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

Kyowa Kirin

Status and phase: Completed; Phase 2; Phase 1

Conditions: X-linked Hypophosphatemia

Treatments: Drug: KRN23

Study type: Interventional

Funder types: Industry

Identifiers

NCT01571596

KRN23-INT-002

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial
2. eGFR ≥ 60 mL/min
3. Corrected Ca < 10.8 mg/dL
4. For female of child-bearing potential, a negative serum pregnancy test
5. A willingness to utilize adequate contraception and not become pregnant [or to have their partner(s) become pregnant] during the study
6. Additional inclusion criteria apply

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

KRN23

Experimental group

Description:

Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)

Treatment:

Drug: KRN23