Back to resultsAn 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
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
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
NCT ID
NCT01460030
First Posted
October 25, 2011
Last Updated
February 28, 2017
Sponsor
Kyowa Kirin Co., Ltd.
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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