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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00257920
First received: November 22, 2005
Last updated: December 22, 2009
Last verified: December 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calcium Absorption Fractions Analyzed by Mixed Model [ Time Frame: 42 Days ] [ Designated as safety issue: No ]

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257920

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

Additional Information:
No publications provided

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
Study First Received: November 22, 2005
Results First Received: January 26, 2009
Last Updated: December 22, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014