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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000695000

Enrollment

Registered

2010-08-23

Start date

2008-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 if their intact parathyroid hormone was >180 pg/ml at the previous study visit, unless serum calcium was <8.4 mg/dl.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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/dL

Exclusion criteria

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

Outcome results