Completed

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

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

Over 20 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2003
See protocol details

Summary

Principal SponsorAbbott
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2003

Actual date on which the first participant was enrolled.

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).

Official TitleA Randomized, Active-Controlled, Double-Blind Multi-Center Study to Compare Initial Dosing Parameters of Zemplar in Stage V Chronic Kidney Disease Subjects on Hemodialysis
NCT00091481
Principal SponsorAbbott
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

201 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

2 inclusion criteria required to participate
Stage V Chronic Kidney Disease
Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

Errikos Dynan Hospital

Ambelokipi, GreeceOpen Errikos Dynan Hospital in Google Maps
Suspended

General Hospital of Athens, "G.Gennimatas"

Cholargós, Greece
Suspended

General Hospital of Attica "Sismanoglio"

Marousi, Greece
Suspended

"Hygeia" Diagnosis and Therapy Center

Marousi, Greece
Completed19 Study Centers