Completed

Effects of Zemplar and Calcijex on Calcium Absorption in Hemodialysis Patients

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+13

+ Chronic Disease

+ Endocrine System Diseases

Over 20 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2004
See protocol details

Summary

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

Study start date: September 1, 2004

Actual date on which the first participant was enrolled.

This research focuses on understanding how two medications, Zemplar Injection and Calcijex, affect the way calcium is absorbed in the intestines of individuals undergoing hemodialysis. Hemodialysis is a treatment for kidney failure that uses a machine to filter the blood. The study aims to compare the effectiveness of these two drugs in improving calcium absorption, a common issue in people with kidney disease. This research is important as it could lead to improved treatment options for managing calcium levels in hemodialysis patients. During the study, participants receive both Zemplar Injection and Calcijex at different times in a specific order, known as a cross-over design. The main goal is to measure and compare the calcium absorption rates between the two treatment regimens. To do this, researchers use a statistical method called ANOVA, which is suitable for this type of two-period cross-over trial. The study's results will help determine which medication is more effective in enhancing calcium absorption.

Official TitleA Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
NCT00073710
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

30 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 DiseaseEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHyperparathyroidismHyperparathyroidism, SecondaryKidney DiseasesParathyroid DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

9 inclusion criteria required to participate
Subject is ≥ 20 years of age.
Subject is diagnosed with ESRD, and must be on maintenance hemodialysis (HD) three times a week for at least 2 months prior to the Screening Phase and expected to remain on HD for the duration of the study.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD), contraceptives (oral or parenteral) for three months prior to study drug administration, or in a monogamous relationship with a vasectomized partner.
If female, subject is not breastfeeding and has a negative serum pregnancy test prior to the treatment phase.
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6 exclusion criteria prevent from participating
Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
Subject has chronic gastrointestinal disease, which in the Investigator's opinion, may result in clinically significant GI malabsorption.
Liver function defects defined as > 2 times the upper limit of normal for liver enzyme or > 1.5 times the upper limit of normal coagulation levels.
Subject is taking maintenance calcitonin, glucocorticoids in an equivalent dose > 5 mg prednisone, or other drugs that may affect calcium or bone metabolism, other than females on stable (same dose and product for 3 months) estrogen and/or progestin therapy.
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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

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 1 location

Suspended

Creighton University

Omaha, United StatesOpen Creighton University in Google Maps
CompletedOne Study Center