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Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307840
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : March 28, 2006
Information provided by:
Papageorgiou General Hospital

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)

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: paricalcitol Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Initial Dosing of Paricalcitol Based on iPTH Parathyroid Hormone Levels in Hemodialysis Patients With Secondary Hyperparathyroidism
Study Start Date : February 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. The frequency of over-suppression of iPTH (< 150 pg/mL) was the secondary outcome.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00307840

Sponsors and Collaborators
Papageorgiou General Hospital
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Principal Investigator: Efstathios Mitsopoulos, MD Papageorgiou General Hospital, Thessaloniki, Greece
Layout table for additonal information Identifier: NCT00307840    
Other Study ID Numbers: 48/4-2-2005
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: March 28, 2006
Last Verified: August 2005
Keywords provided by Papageorgiou General Hospital:
hemodialysis; secondary hyperparathyroidism; hypercalcemia; hyperphosphatemia; vitamin D
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism, Secondary
Neoplastic Processes
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases