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Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

NCT ID: NCT00891813

Last Updated: 2011-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.

Detailed Description

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The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.

Conditions

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Secondary Hyperparathyroidism Renal Insufficiency, Chronic Parathyroid Hormone Hemodialysis Hypercalcemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zemplar (paracalcitol)

Group Type EXPERIMENTAL

Zemplar (paricalcitol)

Intervention Type DRUG

Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.

Interventions

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Zemplar (paricalcitol)

Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.

Intervention Type DRUG

Other Intervention Names

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ABT-358 paricalcitol Zemplar

Eligibility Criteria

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Inclusion Criteria

* Patients \>=18 years old with secondary hyperparathyroidism (PTH\>300pg/mL, measured in the last 2 weeks).
* Patients on hemodialysis who require starting therapy with IV paricalcitol (de novo).
* Patients attending 3 hemodialysis sessions per week.
* Patients signing the informed consent approved by the Ethics Committee. If any individual is not capable of giving his/her consent, it can be obtained from a next of kin or from his/her legal representative, according to local laws and regulations.
* The decision to initiate treatment is upon the investigator and the decision to treat patients with IV paricalcitol must not be based on the inclusion of the patient in the study or any other way. The decision to treat a patient with IV paricalcitol will be taken prior to asking the patient to participate in the study.

Exclusion Criteria

* Patients with any concomitant clinical condition that, according to the investigator's opinion, might impede an adequate assessment of the treatment response.
* Patients with severe hyperparathyroidism (PTH\>3000pg/mL).
* Patients with a serum calcium level greater or equal to 10.5mg/dL, phosphorus greater or equal to 6.5mg/dL, or those with Calcium X Phosphorus product 65 (measured at least 2 weeks before the study).
* Patients with neoplastic disease.
* Pregnant or lactating women.
* Known hypersensitivity and/or toxicity to vitamin D metabolites and/or to other ingredients of the product.
* Having participated in another study with an investigational product or device within the previous 30 days or having planned to participate in another study within the same period of time as the actual study.
* Use of vitamin D analogue during the last 3 months prior to the inclusion to this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oscar E Guerra, MD

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 21401

Callao, , Peru

Site Status

Site Reference ID/Investigator# 23857

Lima, , Peru

Site Status

Site Reference ID/Investigator# 10941

Lima, , Peru

Site Status

Countries

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Peru

Other Identifiers

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W10-677

Identifier Type: -

Identifier Source: org_study_id