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

NCT03280264 | Completed Phase 3 Results

• 1 other identifier: 7580-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Parathyroid Carcinoma; Primary Hyperparathyroidism

Outcome Measures

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.

  Up to 24 weeks

Secondary Outcomes (4)

• 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.

  up to 24 weeks

• Serum Corrected Ca Level

  up to 52 weeks

• Serum Intact Parathyroid Hormone Level

  up to 52 weeks

• Serum Whole Parathyroid Hormone Level

  up to 52 weeks

Study Arms (1)

KHK7580

EXPERIMENTAL

oral administration

Drug: KHK7580

Interventions

KHK7580 DRUG

oral administration

Also known as: evocalcet

KHK7580

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Osaka City University Hospital

Ōsaka, Japan

Location

MeSH Terms

Conditions

Parathyroid Neoplasms; Hyperparathyroidism, Primary

Interventions

evocalcet

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism

Results Point of Contact

• Title: Research & Development Planning Department, Research & Development Division
• Organization: Kyowa Kirin Co., Ltd.

clinical.info.jp@kyowakirin.com

+81-3-5205-7200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 12, 2017
• Study Start: August 30, 2017
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: May 27, 2021
• Results First Posted: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)