Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2018-09-11

Brief Summary

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This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.

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Detailed Description

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Conditions

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Secondary Hyperparathyroidism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose-adjusted SK-1403

Group Type EXPERIMENTAL

Dose-adjusted SK-1403

Intervention Type DRUG

SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment

Interventions

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Dose-adjusted SK-1403

SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Average serum PTH\>240 pg/mL during 2 weeks at the screening
* Serum corrected Ca≧8.4 mg/dL at the screening
* Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration

Exclusion Criteria

* Primary hyperparathyroidism
* Severe liver disease
* Severe Cardiac disease
* History or family history of Long QT syndrome
* Malignant tumor
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* A history of severe drug allergy

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No