Neoplasms

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Cinacalcet

Hormones

Calcium

Calcium, Dietary

Hormone Antagonists

Placebo

KHK7580 low dose

KHK7580 middle dose

KHK7580 high dose

KRN1493

This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.

Phase 2 Study of KHK7580

A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis

Percent changes in intact Parathyroid hormone levels from baseline to end of administration period

Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.

1. Number and types of adverse events
2. laboratory tests
3. vital signs
4. 12-lead electrocardiogram
5. ophthalmological examination

Kyowa Kirin Co., Ltd.

KHK7580

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

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 2 Study of KHK7580	NCT02216656	Secondary Hyper...	Placebo KHK7580 low dos... KHK7580 middle ... KHK7580 high do... KRN1493	20 Years - 74 Years	Kyowa Kirin Co., Ltd.
Phase 3 Study of KHK7580	NCT02549391	Secondary Hyper...	KHK7580 KRN1493	20 Years -	Kyowa Kirin Co., Ltd.

Spots Global Cancer Trial Database for krn1493

Every month we try and update this database with for krn1493 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 krn1493

Every month we try and update this database with for krn1493 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 krn1493 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.