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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460030
First Posted: October 26, 2011
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
  Purpose
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 Intervention Phase
Parathyroid Carcinoma Hypercalcemia Primary Hyperparathyroidism Drug: Cinacalcet HCl Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • Corrected serum calcium

Secondary Outcome Measures:
  • Serum intact parathyroid hormone

Study Start Date: November 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KRN1493 Drug: Cinacalcet HCl
Oral administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
Japan
Sendai, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01460030     History of Changes
Other Study ID Numbers: KRN1493-101
First Submitted: October 25, 2011
First Posted: October 26, 2011
Last Update Posted: March 3, 2017
Last Verified: February 2017

Keywords provided by Kyowa Hakko Kirin Co., Ltd:
Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT

Additional relevant MeSH terms:
Hyperparathyroidism, Primary
Carcinoma
Hyperparathyroidism
Hypercalcemia
Parathyroid Neoplasms
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 Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs