Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
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
1 other identifier
interventional
201
1 country
19
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2004
CompletedFirst Posted
Study publicly available on registry
September 13, 2004
CompletedSeptember 26, 2007
September 1, 2007
September 9, 2004
September 23, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Stage V Chronic Kidney Disease
- Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (19)
Errikos Dynan Hospital
Ambelokipi, Athens, 11526, Greece
General Hospital of Athens, "G.Gennimatas"
Cholargós, Athens, 11527, Greece
General Hospital of Attica "Sismanoglio"
Marousi, Athens, 15126, Greece
"Hygeia" Diagnosis and Therapy Center
Marousi, Athens, 152 00, Greece
General Hospital of Melissia "Amalia Fleming"
Melíssia, Athens, 15127, Greece
General Hospital of Voula Askilpieion
Voula, Athens, 16673, Greece
General Hospital of Heraklion
Voutes, Heraklion, Crete, Greece
General Hospital Thessaloniki "Papanikolaou"
Eksochi, Thessaloniki, 570 10, Greece
General Hospital of Veria
Papagou Area, Veria, Greece
Blue Cross Clinic
Athens, 11528, Greece
Evgenidio Clinic
Athens, 11528, Greece
Regional General Hospital of Athens "Korgialeneio-Benakeio"
Athens, Greece
General University Hospital of Alexandroupolis
Dragana, 68100, Greece
Regional General Hospital of Ioannina "Hatzikosta"
Ioannina, 450 01, Greece
General University Hospital Ioannina
Ioannina, 455 00, Greece
General Hospital of Nikea "Agios Panteleimon"
Nikea, Piraeus 18454,, Greece
General Hospital of Thessaloniki "Ahepa"
Thessaloniki, Greece
General Hospital of Thessaloniki "Hippokrateion"
Thessaloniki, Greece
General Hospital of Thessaloniki "Papageorgiou"
Thessaloniki, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jin Tian, M.D.
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2004
First Posted
September 13, 2004
Study Start
June 1, 2003
Last Updated
September 26, 2007
Record last verified: 2007-09