An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients with Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism.
- Conditions
- Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT.
- Registration Number
- JPRN-jRCT2080221630
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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 follow: 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.
- 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
- Primary Outcome Measures
Name Time Method Corrected serum calcium
- Secondary Outcome Measures
Name Time Method Serum intact parathyroid hormone