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A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257920
First Posted: November 24, 2005
Last Update Posted: December 24, 2009
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.
Information provided by:
Abbott
  Purpose
The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.

Condition Intervention Phase
Chronic Kidney Disease, Stage 5 Secondary Hyperparathyroidism Drug: Zemplar® injection Drug: Hectorol® injection Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Single-Center, Open-Label, Randomized, Active-Controlled, Cross-over Pilot Study to Evaluate the Effects of Two Vitamin D Analogs, Zemplar® Injection and Hectorol® Injection, on Intestinal Absorption of Calcium in CKD Stage 5 Subjects on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA) [ Time Frame: 42 Days ]

Secondary Outcome Measures:
  • Calcium Absorption Fractions Analyzed by Mixed Model [ Time Frame: 42 Days ]

Enrollment: 41
Study Start Date: June 2006
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Zemplar® injection
6 mcg QOD
Other Names:
  • ABT-358
  • paricalcitol
  • Zemplar
Active Comparator: B Drug: Hectorol® injection
3.6 mcg QOD
Other Name: Hectorol®

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is >= 20 years of age.
  • Subject is diagnosed with CKD Stage 5, and must be on maintenance (chronic) hemodialysis (HD) three times a week for at least 2 months prior to the Screening Visit 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 has an intact PTH value > 200 pg/mL at Screening only (or Re-screening, if applicable).
  • Subject has a serum calcium level < 10.2 mg/dL at Screening only (or Re-screening, if applicable).
  • Subject has a serum phosphorus level < 6.5 mg/dL at Screening only (or Re-screening, if applicable).
  • Subject has a CaxP product <= 65 at Screening only (or Re-screening, if applicable).
  • Subject 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 (SGOT/AST, SGPT/ALT) levels.
  • Subject has a hemoglobin level < 9.0 g/dL.
  • Subject is taking maintenance calcitonin, Sensipar® (cinacalcet), glucocorticoids in an equivalent dose > 5 mg prednisone daily, or other drugs that may affect calcium or bone metabolism within 2 weeks prior to screening, 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257920


Locations
United States, Nebraska
Bellevue, Nebraska, United States, 68123
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Abbott
  More Information

Responsible Party: Dennis Andress, MD, Senior Medical Director, Renal Global Project Team, Abbott
ClinicalTrials.gov Identifier: NCT00257920     History of Changes
Other Study ID Numbers: M04-726
First Submitted: November 22, 2005
First Posted: November 24, 2005
Results First Submitted: January 26, 2009
Results First Posted: May 20, 2009
Last Update Posted: December 24, 2009
Last Verified: December 2009

Keywords provided by Abbott:
Stage 5 Chronic Kidney Disease (CKD)

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Ergocalciferols
1 alpha-hydroxyergocalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents