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Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00307840
First Posted: March 28, 2006
Last Update Posted: March 28, 2006
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.
Information provided by:
Papageorgiou General Hospital
  Purpose
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 Intervention Phase
Secondary Hyperparathyroidism Drug: paricalcitol Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Papageorgiou General Hospital:

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

Study Start Date: February 2005
Estimated Study Completion Date: July 2005
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).
  Eligibility

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

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00307840


Sponsors and Collaborators
Papageorgiou General Hospital
Investigators
Principal Investigator: Efstathios Mitsopoulos, MD Papageorgiou General Hospital, Thessaloniki, Greece
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00307840     History of Changes
Other Study ID Numbers: 48/4-2-2005
First Submitted: March 27, 2006
First Posted: March 28, 2006
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:
Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents