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

Last updated: March 6, 2020
Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Parathyroid Disease

Hyperparathyroidism

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT03626948
AJ1003
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 hemodialysisfiltration

Exclusion

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

Total Participants: 157
Study Start date:
September 13, 2018
Estimated Completion Date:
February 05, 2020

Connect with a study center

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

    Tokyo,
    Japan

    Site Not Available

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