Neoplasms

All Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Carcinoma

Hyperparathyroidism

Hyperparathyroidism, Primary

Hypercalcemia

Parathyroid Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Parathyroid Diseases

Endocrine System Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Primary Hyperparathyroidism

Parathyroid Carcinoma

All Drugs and Chemicals

Parathyroid Hormone

KHK7580

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.

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

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

Kyowa Kirin Co., Ltd.

KHK7580 was orally administered daily for up to week 52.

KHK7580 (2-24 mg)

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Japan

Region of Enrollment

serum corrected Ca conc.

serum intact Parathyroid Hormone conc.

parathyroid carcinoma

Unable to undergo parathyroidectomy

Relapse after parathyroidectomy

previous cinacalcet use

Pharmacotherapy for primary diseases

parathyroidectomy

Parathyroid intervention therapy

Research & Development Planning Department, Research & Development Division

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.

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.

Serum Corrected Ca Level

Serum Intact Parathyroid Hormone Level

Serum Whole Parathyroid Hormone Level

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Hyperparathyroidism, Secondary

Neoplastic Processes

This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.

Phase 3 Study of KHK7580

Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.

Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram

intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin

Bone Density Conservation Agents

Cinacalcet

Hormones

Calcium

Calcium, Dietary

Hormone Antagonists

Cinacalcet Hydrochloride

The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.

Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis

Kyowa Kirin China Pharmaceutical Co., Ltd.

Kyowa Kirin Korea Co., Ltd.

KRN1493

The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.

Phase 3 Study of KHK7580 (A Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)

This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.

Phase 3 Study of KHK7580 (A Clinical Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Peritoneal Dialysis)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism	NCT03280264	Parathyroid Car... Primary Hyperpa...	KHK7580	20 Years -	Kyowa Kirin Co., Ltd.
Phase 3 Study of KHK7580	NCT02549404	Secondary Hyper...	KHK7580	20 Years -	Kyowa Kirin Co., Ltd.
Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis	NCT02143271	Secondary Hyper...	KHK7580	20 Years - 74 Years	Kyowa Kirin Co., Ltd.
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia	NCT03822507	Secondary Hyper...	KHK7580 Cinacalcet Hydr...	18 Years -	Kyowa Kirin Co., Ltd.
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism	NCT03280264	Parathyroid Car... Primary Hyperpa...	KHK7580	20 Years -	Kyowa Kirin Co., Ltd.
Phase 3 Study of KHK7580	NCT02549404	Secondary Hyper...	KHK7580	20 Years -	Kyowa Kirin Co., Ltd.
Phase 3 Study of KHK7580	NCT02549404	Secondary Hyper...	KHK7580	20 Years -	Kyowa Kirin Co., Ltd.
Phase 3 Study of KHK7580	NCT02549391	Secondary Hyper...	KHK7580 KRN1493	20 Years -	Kyowa Kirin Co., Ltd.
Phase 3 Study of KHK7580	NCT02549417	Secondary Hyper...	KHK7580	20 Years -	Kyowa Kirin Co., Ltd.

Spots Global Cancer Trial Database for khk7580

Every month we try and update this database with for khk7580 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for khk7580

Every month we try and update this database with for khk7580 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for khk7580 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.