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NCT01460030 Clinical Trial

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

Primary Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01460030
Other study ID # KRN1493-101
Secondary ID
Status Completed
Phase Phase 3
First received October 25, 2011
Last updated February 28, 2017
Start date November 2011
Est. completion date February 2013

Study information
Verified date February 2017
Source Kyowa Hakko Kirin Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Cinacalcet HCl
Oral administration

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corrected serum calcium
Secondary Serum intact parathyroid hormone
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