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
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: 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 July 20, 2014