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

Phase 4

Completed

• Conditions: Kidney Failure, Chronic

• Registration Number: NCT00091481
• Lead Sponsor: Abbott

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2004-09-09
• Study First Submitted QC: 2004-09-10
• Study First Posted: 2004-09-13
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-23
• Last Update Posted: 2007-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The incidence rate for hypercalcemia
Evaluate the number of days to achieve the first of 2 consecutive > or = 30% decreases from baseline in PTH
The incidence rate for hyperphosphatemia

Trial Locations

Locations (19)

General Hospital of Heraklion; 🇬🇷 Voutes, Heraklion, Crete, Greece

General Hospital of Melissia "Amalia Fleming"; 🇬🇷 Melissia, Athens, Greece

General University Hospital of Alexandroupolis; 🇬🇷 Dragana, Greece

General University Hospital Ioannina; 🇬🇷 Ioannina, Greece

Errikos Dynan Hospital; 🇬🇷 Ambelokipi, Athens, Greece

General Hospital of Athens, "G.Gennimatas"; 🇬🇷 Holargos, Athens, Greece

Blue Cross Clinic; 🇬🇷 Athens, Greece

"Hygeia" Diagnosis and Therapy Center; 🇬🇷 Marousi, Athens, Greece

General Hospital of Voula Askilpieion; 🇬🇷 Voula, Athens, Greece

General Hospital Thessaloniki "Papanikolaou"; 🇬🇷 Exohi, Thessaloniki, Greece

Evgenidio Clinic; 🇬🇷 Athens, Greece

Regional General Hospital of Ioannina "Hatzikosta"; 🇬🇷 Ioannina, Greece

General Hospital of Veria; 🇬🇷 Papagou Area, Veria, Greece

Regional General Hospital of Athens "Korgialeneio-Benakeio"; 🇬🇷 Athens, Greece

General Hospital of Thessaloniki "Hippokrateion"; 🇬🇷 Thessaloniki, Greece

General Hospital of Thessaloniki "Papageorgiou"; 🇬🇷 Thessaloniki, Greece

General Hospital of Attica "Sismanoglio"; 🇬🇷 Marousi, Athens, Greece

General Hospital of Nikea "Agios Panteleimon"; 🇬🇷 Nikea, Piraeus 18454,, Greece

General Hospital of Thessaloniki "Ahepa"; 🇬🇷 Thessaloniki, Greece