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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00091481
First received: September 9, 2004
Last updated: September 23, 2007
Last verified: September 2007
History of Changes
  Purpose

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 Intervention Phase
Kidney Failure, Chronic
 Drug: Zemplar
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

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

Enrollment: 201
Study Start Date: June 2003
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage V Chronic Kidney Disease
  • Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091481

Locations
Greece
Errikos Dynan Hospital
Ambelokipi, Athens, Greece, 11526
General Hospital of Athens, "G.Gennimatas"
Holargos, Athens, Greece, 11527
General Hospital of Attica "Sismanoglio"
Marousi, Athens, Greece, 15126
"Hygeia" Diagnosis and Therapy Center
Marousi, Athens, Greece, 152 00
General Hospital of Melissia "Amalia Fleming"
Melissia, Athens, Greece, 15127
General Hospital of Voula Askilpieion
Voula, Athens, Greece, 16673
General Hospital of Heraklion
Voutes, Heraklion, Crete, Greece
General Hospital Thessaloniki "Papanikolaou"
Exohi, Thessaloniki, Greece, 570 10
General Hospital of Veria
Papagou Area, Veria, Greece
Regional General Hospital of Athens "Korgialeneio-Benakeio"
Athens, Greece
Blue Cross Clinic
Athens, Greece, 11528
Evgenidio Clinic
Athens, Greece, 11528
General University Hospital of Alexandroupolis
Dragana, Greece, 68100
Regional General Hospital of Ioannina "Hatzikosta"
Ioannina, Greece, 450 01
General University Hospital Ioannina
Ioannina, Greece, 455 00
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
Sponsors and Collaborators
Abbott
Investigators
Study Director: Jin Tian, M.D. Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00091481     History of Changes
Other Study ID Numbers: M01-367
Study First Received: September 9, 2004
Last Updated: September 23, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Stage V Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013