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

Phase 4

Completed

• Conditions: Hemodialysis patients with secondary hyperparathyroidism; Renal and Urogenital - Kidney disease; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12610000695000
• Lead Sponsor: Kobe University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Receiving maintenance dialysis for at least 16 weeks
2. Serum intact parathyroid hormone >300 pg/mL
3. Corrected serum calcium >9.0 mg/d

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a mean intact parathyroid hormone <180 pg/ml, as evaluated by the Elecsys assay, during the efficacy-assessment phase.[After 52-weeks of treatment]

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with a <30% reduction from baseline in intact parathyroid hormone, as evaluated by the Elecsys assay.[After 52-weeks of treatment];Percent change from baseline in calcium, phosphorus, and intact parathyroid hormone, as evaluated by the Elecsys assay.[After 52-weeks of treatment];Change from baseline in parathyroid gland volume, as evaluated by ultrasonography.[After 52-weeks of treatment]