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Completed

NCT Number: NCT03801980

Phase 3 Study of SK-1403

To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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

  • 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
  • History of severe drug allergy

Treatment and study plan

SK-1403

Drug

Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.

Placebo

Drug

Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.

Primary outcomes

  1. Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.

    Time frame: 24 weeks

    Assessed by laboratory test value

Secondary outcomes

  1. Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.

    Time frame: 24 weeks

    Assessed by laboratory test value

  2. Measured values and Changes from baseline in serum PTH

    Time frame: 24 weeks

    Assessed by laboratory test value; unit of measure (pg/mL)

  3. Measured values and Changes from baseline in Ca

    Time frame: 24 weeks

    Assessed by laboratory test value; unit of measure (mg/dL)

  4. Measured values and Changes from baseline in ionized Ca

    Time frame: 24 weeks

    Assessed by laboratory test value; unit of measure (mEq/dL)

  5. Measured values and Changes from baseline in P

    Time frame: 24 weeks

    Assessed by laboratory test value; unit of measure (mg/dL)

  6. Measured values and Changes from baseline in serum Ca x P product

    Time frame: 24 weeks

    Assessed by laboratory test value

Sponsors and collaborators

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Industry

Registry information

Official study title

Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2019
Registry last updated
Mar 9, 2020

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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