We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03280264
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

Condition or disease Intervention/treatment Phase
Parathyroid Carcinoma Primary Hyperparathyroidism Drug: KHK7580 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Intra-Subject Dose-Adjustment Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism Who Are Unable to Undergo Parathyroidectomy or Relapse After Parathyroidectomy
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : October 2019


Arms and Interventions

Arm Intervention/treatment
Experimental: KHK7580
oral administration
Drug: KHK7580
oral administration
Other Name: evocalcet


Outcome Measures

Primary Outcome Measures :
  1. Percentage of subjects whose corrected serum calcium level is maintained ≤ 10.3 mg/dL for 2 weeks in the evaluation period. [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Percentage of subjects whose corrected serum calcium level decreases by ≥1.0 mg/dL from baseline and the decrease is maintained for 2 weeks in the evaluation period. [ Time Frame: up to 24 weeks ]
  2. Corrected serum calcium level [ Time Frame: up to 52 weeks ]
  3. intact Parathyroid Hormone (PTH) level [ Time Frame: up to 52 weeks ]
  4. whole PTH level [ Time Frame: up to 52 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Personally submitted written voluntary informed consent to participate in the study
  • Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.
  • Corrected serum calcium level is > 11.3 mg/dL at screening.

Exclusion Criteria:

  • Patients receiving cinacalcet hydrochloride within 2 weeks before screening
  • Patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma.
  • Severe heart disease
  • Severe hepatic dysfunction
  • Uncontrolled hypertension and/or diabetes
  • Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening
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): NCT03280264


Contacts
Contact: Kyowa Hakko Kirin Co., Ltd. clinical.info@kyowa-kirin.co.jp

Locations
Japan
Osaka City University Hospital Recruiting
Ōsaka, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT03280264     History of Changes
Other Study ID Numbers: 7580-101
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Hyperparathyroidism
Hyperparathyroidism, Primary
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