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

Primary Purpose

Parathyroid Carcinoma, Hypercalcemia, Primary Hyperparathyroidism

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Cinacalcet HCl
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parathyroid Carcinoma focused on measuring Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KRN1493

Arm Description

Outcomes

Primary Outcome Measures

Corrected serum calcium

Secondary Outcome Measures

Serum intact parathyroid hormone

Full Information

First Posted
October 25, 2011
Last Updated
February 28, 2017
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01460030
Brief Title
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
Official Title
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Carcinoma, Hypercalcemia, Primary Hyperparathyroidism
Keywords
Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
KRN1493
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cinacalcet HCl
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Corrected serum calcium
Secondary Outcome Measure Information:
Title
Serum intact parathyroid hormone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Sendai
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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