Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism - Full Text View

Sponsored by:	Papageorgiou General Hospital
Information provided by:	Papageorgiou General Hospital
ClinicalTrials.gov Identifier:	NCT00307840

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Initial Dosing of Paricalcitol Based on iPTH Parathyroid Hormone Levels in Hemodialysis Patients With Secondary Hyperparathyroidism

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307840

Sponsors and Collaborators

Papageorgiou General Hospital

Investigators

Principal Investigator:

Efstathios Mitsopoulos, MD

Papageorgiou General Hospital, Thessaloniki, Greece

More Information

Publications:

Martin KJ, Gonzalez E, Lindberg JS, Taccetta C, Amdahl M, Malhotra K, Llach F. Paricalcitol dosing according to body weight or severity of hyperparathyroidism: a double-blind, multicenter, randomized study. Am J Kidney Dis. 2001 Nov;38(5 Suppl 5):S57-63.

Study ID Numbers:	48/4-2-2005
Study First Received:	March 27, 2006
Last Updated:	March 27, 2006
ClinicalTrials.gov Identifier:	NCT00307840 History of Changes
Health Authority:	Greece: Ministry of Health and Welfare

Keywords provided by Papageorgiou General Hospital:

hemodialysis; secondary hyperparathyroidism; hypercalcemia; hyperphosphatemia; vitamin D

Study placed in the following topic categories:

Parathyroid Diseases
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Vitamins
Hypercalcemia

Neoplasm Metastasis
Endocrine System Diseases
Hyperphosphatemia
Endocrinopathy
Hormones

Additional relevant MeSH terms:

Parathyroid Diseases
Neoplasms
Neoplastic Processes
Hyperparathyroidism, Secondary

Pathologic Processes
Hyperparathyroidism
Neoplasm Metastasis
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 11, 2009