CompletedPhase 4ACTRN12610000695000

Parathyroid gland size and responsiveness to cinacalcet therapy in hemodialysis patients with secondary hyperparathyroidism


Sponsor

Kobe University School of Medicine

Enrollment

75 participants

Start Date

Jan 1, 2008

Study Type

Interventional

Conditions

Summary

The purpose of this study was twofold: (1) to elucidate whether parathyroid gland size could be used as an indicator of response to cinacalcet therapy and (2) to examine whether cinacalcet reduces parathyroid gland volume in patients with secondary hyperparathyroidism.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • Receiving maintenance dialysis for at least 16 weeks
  • Serum intact parathyroid hormone >300 pg/mL
  • Corrected serum calcium >9.0 mg/dL

Exclusion Criteria1

  • History of parathyroidectomy or an unstable medical condition during the previous 30 days.

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Interventions

Cinacalcet hydrochloride, 25 mg once daily, given orally, for 52 weeks. The doses were increased to the next sequential daily dose in the series 25, 50, 75, and 100 mg after at least a 3-week interval

Cinacalcet hydrochloride, 25 mg once daily, given orally, for 52 weeks. The doses were increased to the next sequential daily dose in the series 25, 50, 75, and 100 mg after at least a 3-week interval if their intact parathyroid hormone was >180 pg/ml at the previous study visit, unless serum calcium was <8.4 mg/dl.


Locations(1)

Japan

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ACTRN12610000695000