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
  Purpose

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


Condition Intervention Phase
Secondary Hyperparathyroidism
Chronic Kidney Disease
Drug: Zemplar
Procedure: 42 Ca carbonate absorption via single tracer method
Drug: Calcijex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

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.

Estimated Enrollment: 30
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073710

Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Abbott
Investigators
Principal Investigator: Richard Lund, M.D. Creighton University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00073710     History of Changes
Other Study ID Numbers: M01-375
Study First Received: December 3, 2003
Last Updated: July 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
secondary hyperparathyroidism

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Endocrine System Diseases
Parathyroid Diseases
Renal Insufficiency
Urologic Diseases
Calcitriol
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on October 21, 2014