Expired Study
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Omaha, Nebraska 68131


A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.


Inclusion Criteria - 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 - 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. - Subject had an intact PTH value > 200 pg/mL. - Serum calcium level < 10.2 mg/dL at Screening visit. - Serum phosphorus level < 6.5 mg/dL at Screening visit. - Ca´P product ≤ 65 at Screening visit. - Must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedure Exclusion Criteria - 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. - For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive pharmacological doses of vitamin D. - Subject has received any investigational drug within 4 weeks prior to the Treatment Phase.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium

Official Title:

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

Overall Status:


Study Phase:

Phase 4



Minimum Age:

20 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:


Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Richard Lund, M.D.
Principal Investigator
Creighton University

Study Dates

Start Date:September 2004
Verification Date:July 2006
Last Changed Date:July 31, 2006
First Received Date:December 3, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:The mean within subject difference in calcium absorption rates between treatment regimens will be analyzed using ANOVA appropriate for a two-period cross-over trial.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Intervention Type:Procedure
Name:42 Ca carbonate absorption via single tracer metho
Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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