Clinical trial NCT00091481: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Keywords: Stage V Chronic Kidney Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2004-09-13
Enrollment: 201
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Incidence rate of at least two consecutive calcium-phosphorus product levels greater than 65.
Secondary outcomes:
measure: Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH
measure: The incidence rate for hypercalcemia
measure: The incidence rate for hyperphosphatemia
Other outcomes:
Locations:
city: Ambelokipi
country: Greece
facility: Errikos Dynan Hospital
state: Athens
city: Holargos
country: Greece
facility: General Hospital of Athens, "G.Gennimatas"
state: Athens
city: Marousi
country: Greece
facility: General Hospital of Attica "Sismanoglio"
state: Athens
city: Marousi
country: Greece
facility: "Hygeia" Diagnosis and Therapy Center
state: Athens
city: Melissia
country: Greece
facility: General Hospital of Melissia "Amalia Fleming"
state: Athens
city: Voula
country: Greece
facility: General Hospital of Voula Askilpieion
state: Athens
city: Voutes, Heraklion
country: Greece
facility: General Hospital of Heraklion
state: Crete
city: Exohi
country: Greece
facility: General Hospital Thessaloniki "Papanikolaou"
state: Thessaloniki
city: Papagou Area
country: Greece
facility: General Hospital of Veria
state: Veria
city: Athens
country: Greece
facility: Blue Cross Clinic
city: Athens
country: Greece
facility: Evgenidio Clinic
city: Athens
country: Greece
facility: Regional General Hospital of Athens "Korgialeneio-Benakeio"
city: Dragana
country: Greece
facility: General University Hospital of Alexandroupolis
city: Ioannina
country: Greece
facility: Regional General Hospital of Ioannina "Hatzikosta"
city: Ioannina
country: Greece
facility: General University Hospital Ioannina
city: Nikea, Piraeus 18454,
country: Greece
facility: General Hospital of Nikea "Agios Panteleimon"
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Ahepa"
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Hippokrateion"
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Papageorgiou"
Study officials:
affiliation: Abbott
name: Jin Tian, M.D.
role: STUDY_DIRECTOR
References: