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CompletedNCT00091481Updated Sep 26, 2007

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

A Phase 4 interventional study of Zemplar in Kidney Failure, Chronic, sponsored by Abbott. Completed at 19 sites in Greece. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2007-09-26.

Sponsored by Abbott · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Kidney Failure, Chronic

Keywords

  • Stage V Chronic Kidney Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 201 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
201 participants (actual)

Interventions

  • DrugZemplar
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH

  2. The incidence rate for hypercalcemia

  3. The incidence rate for hyperphosphatemia

07

Study locations

19 sites
  • Errikos Dynan Hospital
    Ambelokipi, Athens 11526, Greece
  • General Hospital of Athens, "G.Gennimatas"
    Holargos, 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"
    Melissia, Athens 15127, Greece
  • General Hospital of Voula Askilpieion
    Voula, Athens 16673, Greece
  • General Hospital of Heraklion
    Voutes, Heraklion, Crete, Greece
  • General Hospital Thessaloniki "Papanikolaou"
    Exohi, 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00091481
Lead sponsor
Abbott
First posted
Sep 13, 2004
Start date
Jun 2003
Last update
Sep 26, 2007

Study contacts

Jin Tian, M.D.
study director · Abbott
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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