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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


Phase 3
20 Years
N/A
Open (Enrolling)
Both
Parathyroid Carcinoma, Hypercalcemia, Primary Hyperparathyroidism

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Corrected serum calcium

Safety Issue:

No

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

KRN1493-101

NCT ID:

NCT01460030

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Parathyroid Carcinoma
  • Hypercalcemia
  • Primary Hyperparathyroidism
  • Hypercalcemia in patients with parathyroid carcinoma or intractable PHPT
  • Carcinoma
  • Hypercalcemia
  • Hyperparathyroidism
  • Hyperparathyroidism, Primary
  • Parathyroid Neoplasms

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