Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

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)

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Key information

Conditions

Secondary Hyperparathyroidism Calcium Metabolism Disorders Endocrine System Diseases Hypercalcemia Hyperparathyroidism Hyperparathyroidism, Secondary Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Phosphorus Metabolism Disorders Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paricalcitol

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Papageorgiou General Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2005
First posted: Mar 28, 2006
Registry last updated: Mar 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed