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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073710
Recruitment Status : Completed
First Posted : December 4, 2003
Last Update Posted : August 2, 2006
Information provided by:

December 3, 2003
December 4, 2003
August 2, 2006
September 2004
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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.
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Complete list of historical versions of study NCT00073710 on Archive Site
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Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
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
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
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Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
  • Secondary Hyperparathyroidism
  • Chronic Kidney Disease
  • Drug: Zemplar
  • Procedure: 42 Ca carbonate absorption via single tracer method
  • Drug: Calcijex
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Principal Investigator: Richard Lund, M.D. Creighton University
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP