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Completed

NCT Number: NCT03226171

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

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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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dose-adjusted SK-1403

Drug

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

Primary outcomes

  1. Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive

    Time frame: 18 weeks

    Assessed by laboratory test value

Secondary outcomes

  1. Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively

    Time frame: 18 weeks

    Assessed by laboratory test value

  2. Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product

    Time frame: 52 weeks

    Assessed by laboratory test value

Sponsors and collaborators

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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