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

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Zemplar
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Stage V Chronic Kidney Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Errikos Dynan Hospital
  • General Hospital of Athens, "G.Gennimatas"
  • General Hospital of Attica "Sismanoglio"
  • "Hygeia" Diagnosis and Therapy Center
  • General Hospital of Melissia "Amalia Fleming"
  • General Hospital of Voula Askilpieion
  • General Hospital of Heraklion
  • General Hospital Thessaloniki "Papanikolaou"
  • General Hospital of Veria
  • Blue Cross Clinic
  • Evgenidio Clinic
  • Regional General Hospital of Athens "Korgialeneio-Benakeio"
  • General University Hospital of Alexandroupolis
  • Regional General Hospital of Ioannina "Hatzikosta"
  • General University Hospital Ioannina
  • General Hospital of Nikea "Agios Panteleimon"
  • General Hospital of Thessaloniki "Ahepa"
  • General Hospital of Thessaloniki "Hippokrateion"
  • General Hospital of Thessaloniki "Papageorgiou"

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2004
Last Updated
September 23, 2007
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00091481
Brief Title
Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Stage V Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zemplar
Primary Outcome Measure Information:
Title
Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.
Secondary Outcome Measure Information:
Title
Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH
Title
The incidence rate for hypercalcemia
Title
The incidence rate for hyperphosphatemia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Tian, M.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Errikos Dynan Hospital
City
Ambelokipi
State/Province
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
General Hospital of Athens, "G.Gennimatas"
City
Holargos
State/Province
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Attica "Sismanoglio"
City
Marousi
State/Province
Athens
ZIP/Postal Code
15126
Country
Greece
Facility Name
"Hygeia" Diagnosis and Therapy Center
City
Marousi
State/Province
Athens
ZIP/Postal Code
152 00
Country
Greece
Facility Name
General Hospital of Melissia "Amalia Fleming"
City
Melissia
State/Province
Athens
ZIP/Postal Code
15127
Country
Greece
Facility Name
General Hospital of Voula Askilpieion
City
Voula
State/Province
Athens
ZIP/Postal Code
16673
Country
Greece
Facility Name
General Hospital of Heraklion
City
Voutes, Heraklion
State/Province
Crete
Country
Greece
Facility Name
General Hospital Thessaloniki "Papanikolaou"
City
Exohi
State/Province
Thessaloniki
ZIP/Postal Code
570 10
Country
Greece
Facility Name
General Hospital of Veria
City
Papagou Area
State/Province
Veria
Country
Greece
Facility Name
Blue Cross Clinic
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Evgenidio Clinic
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Regional General Hospital of Athens "Korgialeneio-Benakeio"
City
Athens
Country
Greece
Facility Name
General University Hospital of Alexandroupolis
City
Dragana
ZIP/Postal Code
68100
Country
Greece
Facility Name
Regional General Hospital of Ioannina "Hatzikosta"
City
Ioannina
ZIP/Postal Code
450 01
Country
Greece
Facility Name
General University Hospital Ioannina
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
General Hospital of Nikea "Agios Panteleimon"
City
Nikea, Piraeus 18454,
Country
Greece
Facility Name
General Hospital of Thessaloniki "Ahepa"
City
Thessaloniki
Country
Greece
Facility Name
General Hospital of Thessaloniki "Hippokrateion"
City
Thessaloniki
Country
Greece
Facility Name
General Hospital of Thessaloniki "Papageorgiou"
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

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

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