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SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis | Clinical Trials | Clareo Health

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SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

SK-1403 Long-term Treatment Study - Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis -

NCT03626948•Sanwa Kagaku Kenkyusho Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Serum PTH\>240 pg/mL 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

Locations (1)

Investigational site (there may be other sites in this country)

Tokyo, Japan

Key Dates

Start Date

September 13, 2018

Primary Completion Date

February 4, 2020

Completion Date

February 5, 2020

Last Updated

March 9, 2020

Enrollment

157

ACTUAL participants

Conditions

Secondary Hyperparathyroidism

Interventions

SK-1403

DRUG

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

NCT03633708

Secondary HyperparathyroidismChronic Kidney Disease

View study

RECRUITINGNA

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

NCT04922892

Secondary Hyperparathyroidism;Parathyroidectomy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

Inclusion Criteria

Exclusion Criteria

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial

The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD

Diagnostic Accuracy of 3T MR for Secondary Hyperparathyroidism Comparison With 4DCT