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

September 23, 2007 updated by: Abbott

A Randomized, Active-Controlled, Double-Blind Multi-Center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Blue Cross Clinic
      • Athens, Greece, 11528
        • Evgenidio Clinic
      • Athens, Greece
        • Regional General Hospital of Athens "Korgialeneio-Benakeio"
      • Dragana, Greece, 68100
        • General University Hospital of Alexandroupolis
      • Ioannina, Greece, 450 01
        • Regional General Hospital of Ioannina "Hatzikosta"
      • Ioannina, Greece, 455 00
        • General University Hospital Ioannina
      • Nikea, Piraeus 18454,, Greece
        • General Hospital of Nikea "Agios Panteleimon"
      • Thessaloniki, Greece
        • General Hospital of Thessaloniki "Ahepa"
      • Thessaloniki, Greece
        • General Hospital of Thessaloniki "Hippokrateion"
      • Thessaloniki, Greece
        • General Hospital of Thessaloniki "Papageorgiou"
    • Athens
      • Ambelokipi, Athens, Greece, 11526
        • Errikos Dynan Hospital
      • Holargos, Athens, Greece, 11527
        • General Hospital of Athens, "G.Gennimatas"
      • Marousi, Athens, Greece, 15126
        • General Hospital of Attica "Sismanoglio"
      • Marousi, Athens, Greece, 152 00
        • "Hygeia" Diagnosis and Therapy Center
      • Melissia, Athens, Greece, 15127
        • General Hospital of Melissia "Amalia Fleming"
      • Voula, Athens, Greece, 16673
        • General Hospital of Voula Askilpieion
    • Crete
      • Voutes, Heraklion, Crete, Greece
        • General Hospital of Heraklion
    • Thessaloniki
      • Exohi, Thessaloniki, Greece, 570 10
        • General Hospital Thessaloniki "Papanikolaou"
    • Veria
      • Papagou Area, Veria, Greece
        • General Hospital of Veria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage V Chronic Kidney Disease
  • Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.

Secondary Outcome Measures

Outcome Measure
Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH
The incidence rate for hypercalcemia
The incidence rate for hyperphosphatemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Jin Tian, M.D., Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Registration Dates

First Submitted

September 9, 2004

First Submitted That Met QC Criteria

September 10, 2004

First Posted (Estimate)

September 13, 2004

Study Record Updates

Last Update Posted (Estimate)

September 26, 2007

Last Update Submitted That Met QC Criteria

September 23, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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