An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism

Phase 3

Completed

• Conditions: Parathyroid Carcinoma; Hypercalcemia; Primary Hyperparathyroidism
• Interventions: Drug: Cinacalcet HCl

• Registration Number: NCT01460030
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

This is an intra-individual titration study of KRN1493 to evaluate the safety and efficacy of KRN1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (PHPT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-26
• Study Start: 2011-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients who meet any one of the following. Patients with a diagnosis of parathyroid carcinoma and corrected serum calcium > 11.3 mg/dL at the latest screening test. Patients with intractable PHPT (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (PTx) for complications, and corrected serum calcium is > 12.5 mg/dL at the screening test).
• Patients who provided their voluntary written informed consent to participate in the study.

Exclusion Criteria

• Patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment.
• Patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma.
• Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
• Patients who had hypersensitivities to cinacalcet HCl preparations or vehicles.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KRN1493	Cinacalcet HCl	-

Primary Outcome Measures

Name	Time	Method
Corrected serum calcium

Secondary Outcome Measures

Name	Time	Method
Serum intact parathyroid hormone