CompletedNCT03226171Updated Mar 15, 2019

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

A Phase 2 interventional study of Dose-adjusted SK-1403 in Secondary Hyperparathyroidism, sponsored by Sanwa Kagaku Kenkyusho Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by Sanwa Kagaku Kenkyusho Co., Ltd. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 58
Allocation: Not applicable
Ages: 20 Years to 79 Years
Sex: All

Study 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.

Conditions studied

Secondary Hyperparathyroidism

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Who can participate

Ages eligible: 20 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 58 participants (actual)

Study arms

Experimental
Dose-adjusted SK-1403
Drug: Dose-adjusted SK-1403

Interventions

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

What researchers measure

Primary outcomes

Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
Assessed by laboratory test value
Time frame: 18 weeks

Secondary outcomes

Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively
Assessed by laboratory test value
Time frame: 18 weeks
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product
Assessed by laboratory test value
Time frame: 52 weeks

Study locations

1 site

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

Registry details

Key details

Study ID: NCT03226171
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Responsible party: Sponsor
First posted: Jul 21, 2017
Start date: Jun 20, 2017
Primary completion: Sep 11, 2018
Completion: Sep 11, 2018
Last update: Mar 15, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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