Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

Initial Dosing of Paricalcitol Based on iPTH Parathyroid Hormone Levels in Hemodialysis Patients With Secondary Hyperparathyroidism

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00307840

Enrollment

Unknown

Registered

2006-03-28

Start date

2005-02-28

Completion date

2005-07-31

Last updated

2006-03-28

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

Conditions

Secondary Hyperparathyroidism

Keywords

hemodialysis; secondary hyperparathyroidism; hypercalcemia; hyperphosphatemia; vitamin D

Brief summary

The purpose of this study was to compare two different initial dosing schemes for the administration of paricalcitol in hemodialysis patients with secondary hyperparathyroidism: the already in use iPTH/80 scheme, and an iPTH/120 scheme, which corresponds to the immediately lower dose, based on current instructions on paricalcitol dose adjustment. We studied the effectiveness of the two dosing schemes in achieving a target iPTH level (150 - 300 pg/mL)

Detailed description

Adjustment of the initial dose of paricalcitol, in hemodialysis patients with secondary hyperparathyroidism (sHPT), on the basis of severity of sHPT is generally preferred in current practice. Whether the proposed dose, based on the formula baseline intact parathyroid hormone (iPTH \[pg/mL\]) divided by 80, is the most appropriate has not been adequately assessed. A trial comparing the iPTH/80 dose to the immediately lower iPTH/120 dose was undertaken. We studied the ability of the two different dosing schemes to control iPTH levels within a desired range between 150 and 300 pg/mL, as well as the frequency of iPTH over-suppression (\< 150 pg/mL) in the two groups (iPTH/80 and iPTH/120).

Interventions

DRUGparicalcitol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

-maintenance hemodialysis therapy (3 sessions per week) for at least 3 months; iPTH between 300 and 900 pg/mL; age \> 18 years; normal serum calcium concentration (8.1 - 10.4 mg/dL); Ca x P product less than 70; no vitamin D metabolite replacement therapy for at least one month prior to the enrollment; aluminum levels lower than 60 μg/L. \-

Exclusion criteria

administration of calcitonin, disphosphonates or corticosteroids; presence of a clinically serious medical condition; previous parathyroidectomy; active malignancy. \-

Design outcomes

Primary

Measure	Time frame
The primary outcome was the achievement of desired iPTH levels (150 - 300 pg/mL) in the two groups (iPTH/80 and iPTH/120).	—

Secondary

Measure	Time frame
The frequency of over-suppression of iPTH (< 150 pg/mL) was the secondary outcome.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026