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Completed

NCT Number: NCT01460030

An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism

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).

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Key information

Conditions

Parathyroid Carcinoma Calcium Metabolism Disorders Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hypercalcemia Hyperparathyroidism Hyperparathyroidism, Primary Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Parathyroid Diseases Parathyroid Neoplasms Primary Hyperparathyroidism Water-Electrolyte Imbalance

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sendai, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cinacalcet HCl

Drug

Oral administration

Primary outcomes

  1. Corrected serum calcium

Secondary outcomes

  1. Serum intact parathyroid hormone

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2011
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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