Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01460030
First received: October 25, 2011
Last updated: May 13, 2014
Last verified: May 2014
  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 Company, Limited:

Primary Outcome Measures:
  • Corrected serum calcium [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum intact parathyroid hormone [ Designated as safety issue: No ]

Study Start Date: November 2011
Arms Assigned Interventions
Experimental: KRN1493 Drug: Cinacalcet HCl
Oral administration

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460030

Locations
Japan
Sendai, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01460030     History of Changes
Other Study ID Numbers: KRN1493-101
Study First Received: October 25, 2011
Last Updated: May 13, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT

Additional relevant MeSH terms:
Carcinoma
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Neoplasms
Calcium Metabolism Disorders
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Metabolic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Parathyroid Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on November 20, 2014