Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
Study Details
Study Description
Brief Summary
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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. []
Eligibility Criteria
Criteria
Inclusion Criteria
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Subject is ≥ 20 years of age.
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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.
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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:
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Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
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Contraceptives (oral or parenteral) for three months prior to study drug administration
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In a monogamous relationship with a vasectomized partner
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If female, subject is not breastfeeding and has a negative serum pregnancy test prior to the treatment phase.
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Subject had an intact PTH value > 200 pg/mL.
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Serum calcium level < 10.2 mg/dL at Screening visit.
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Serum phosphorus level < 6.5 mg/dL at Screening visit.
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Ca´P product ≤ 65 at Screening visit.
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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
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Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
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Subject has chronic gastrointestinal disease, which in the Investigator's opinion, may result in clinically significant GI malabsorption.
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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.
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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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For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive pharmacological doses of vitamin D.
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Subject has received any investigational drug within 4 weeks prior to the Treatment Phase.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Creighton University | Omaha | Nebraska | United States | 68131 |
Sponsors and Collaborators
- Abbott
Investigators
- Principal Investigator: Richard Lund, M.D., Creighton University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M01-375