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OpenTrials
Completed

NCT Number: NCT03280264

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

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.

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Key information

Conditions

Parathyroid Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hyperparathyroidism Hyperparathyroidism, Primary Neoplasms Neoplasms by Site Parathyroid Diseases Parathyroid Neoplasms Primary Hyperparathyroidism

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Osaka City University Hospital

Ōsaka, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

KHK7580

Drug

oral administration

Other names: evocalcet

Primary outcomes

  1. The Number and Percentage of Patients Who Achived a Serum Corrected Ca Concentration of Under 10.3 mg/dL for at Least 2weeks During Titration Phase.

    Time frame: Up to 24 weeks

Secondary outcomes

  1. The Number and Percentage of Patients in Whom the Decrease in Serum Corrected Ca Concentration From the Baseline Was ≥ 1.0 mg/dL for ≥ 2 Weeks During the Titration Phase.

    Time frame: up to 24 weeks

  2. Serum Corrected Ca Level

    Time frame: up to 52 weeks

  3. Serum Intact Parathyroid Hormone Level

    Time frame: up to 52 weeks

  4. Serum Whole Parathyroid Hormone Level

    Time frame: up to 52 weeks

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2017
Registry last updated
May 27, 2021

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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