Status:
COMPLETED
An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Parathyroid Carcinoma
Hypercalcemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
End Date :
February 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01460030
Start Date
November 1 2011
End Date
February 1 2013
Last Update
March 3 2017
Active Locations (1)
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1
Sendai, Japan