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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00091481

Collaborator

(none)

201

Enrollment

Locations

10.6

Patients Per Site

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic	Drug: Zemplar	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

201 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Errikos Dynan Hospital	Ambelokipi	Athens	Greece	11526
2	General Hospital of Athens, "G.Gennimatas"	Holargos	Athens	Greece	11527
3	General Hospital of Attica "Sismanoglio"	Marousi	Athens	Greece	15126
4	"Hygeia" Diagnosis and Therapy Center	Marousi	Athens	Greece	152 00
5	General Hospital of Melissia "Amalia Fleming"	Melissia	Athens	Greece	15127
6	General Hospital of Voula Askilpieion	Voula	Athens	Greece	16673
7	General Hospital of Heraklion	Voutes, Heraklion	Crete	Greece
8	General Hospital Thessaloniki "Papanikolaou"	Exohi	Thessaloniki	Greece	570 10
9	General Hospital of Veria	Papagou Area	Veria	Greece
10	Blue Cross Clinic	Athens		Greece	11528
11	Evgenidio Clinic	Athens		Greece	11528
12	Regional General Hospital of Athens "Korgialeneio-Benakeio"	Athens		Greece
13	General University Hospital of Alexandroupolis	Dragana		Greece	68100
14	Regional General Hospital of Ioannina "Hatzikosta"	Ioannina		Greece	450 01
15	General University Hospital Ioannina	Ioannina		Greece	455 00
16	General Hospital of Nikea "Agios Panteleimon"	Nikea, Piraeus 18454,		Greece
17	General Hospital of Thessaloniki "Ahepa"	Thessaloniki		Greece
18	General Hospital of Thessaloniki "Hippokrateion"	Thessaloniki		Greece
19	General Hospital of Thessaloniki "Papageorgiou"	Thessaloniki		Greece