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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

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ClinicalTrials.gov Identifier: NCT01460030
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Parathyroid Carcinoma Hypercalcemia Primary Hyperparathyroidism Drug: Cinacalcet HCl Phase 3

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism
Study Start Date : November 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013


Arm Intervention/treatment
Experimental: KRN1493 Drug: Cinacalcet HCl
Oral administration




Primary Outcome Measures :
  1. Corrected serum calcium

Secondary Outcome Measures :
  1. Serum intact parathyroid hormone


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460030


Locations
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Japan
Sendai, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.
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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT01460030    
Other Study ID Numbers: KRN1493-101
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Keywords provided by Kyowa Kirin Co., Ltd.:
Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT
Additional relevant MeSH terms:
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Carcinoma
Parathyroid Neoplasms
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Cinacalcet
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists