Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

NCT ID: NCT00091481

Last Updated: 2007-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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To show non-inferiority in the incidence rates of elevated calcium-phosphorus product between two treatment groups: 1) a group having an initial dose based on baseline PTH (baseline iPTH/80) and 2) a group having a starting dose based on body weight (0.04 mcg/kg).

Detailed Description

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Conditions

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Kidney Failure, Chronic

Keywords

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Stage V Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Zemplar

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage V Chronic Kidney Disease
* Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jin Tian, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

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Errikos Dynan Hospital

Ambelokipi, Athens, Greece

Site Status

General Hospital of Athens, "G.Gennimatas"

Cholargós, Athens, Greece

Site Status

General Hospital of Attica "Sismanoglio"

Marousi, Athens, Greece

Site Status

"Hygeia" Diagnosis and Therapy Center

Marousi, Athens, Greece

Site Status

General Hospital of Melissia "Amalia Fleming"

Melíssia, Athens, Greece

Site Status

General Hospital of Voula Askilpieion

Voula, Athens, Greece

Site Status

General Hospital of Heraklion

Voutes, Heraklion, Crete, Greece

Site Status

General Hospital Thessaloniki "Papanikolaou"

Eksochi, Thessaloniki, Greece

Site Status

General Hospital of Veria

Papagou Area, Veria, Greece

Site Status

Blue Cross Clinic

Athens, , Greece

Site Status

Evgenidio Clinic

Athens, , Greece

Site Status

Regional General Hospital of Athens "Korgialeneio-Benakeio"

Athens, , Greece

Site Status

General University Hospital of Alexandroupolis

Dragana, , Greece

Site Status

Regional General Hospital of Ioannina "Hatzikosta"

Ioannina, , Greece

Site Status

General University Hospital Ioannina

Ioannina, , Greece

Site Status

General Hospital of Nikea "Agios Panteleimon"

Nikea, Piraeus 18454,, , Greece

Site Status

General Hospital of Thessaloniki "Ahepa"

Thessaloniki, , Greece

Site Status

General Hospital of Thessaloniki "Hippokrateion"

Thessaloniki, , Greece

Site Status

General Hospital of Thessaloniki "Papageorgiou"

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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M01-367

Identifier Type: -

Identifier Source: org_study_id