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

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226171
• Other study ID #: AJ1002
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2017
• Est. completion date: September 11, 2018

Study information

• Verified date: March 2019
• Source: Sanwa Kagaku Kenkyusho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

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

Locations

Country	Name	City	State
Japan	Investigational site (there may be other sites in this country)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive	Assessed by laboratory test value	18 weeks
Secondary	Rate of patients who achieved = 30% or 50% reduction in serum PTH from baseline, respectively	Assessed by laboratory test value	18 weeks
Secondary	Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product	Assessed by laboratory test value	52 weeks