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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00073710
First received: December 3, 2003
Last updated: July 31, 2006
Last verified: July 2006

December 3, 2003
July 31, 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 ClinicalTrials.gov 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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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073710
M01-375
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Abbott
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Principal Investigator: Richard Lund, M.D. Creighton University
Abbott
July 2006

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