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

Primary Purpose

Secondary Hyperparathyroidism, Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zemplar
42 Ca carbonate absorption via single tracer method
Calcijex
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring secondary hyperparathyroidism

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Creighton University

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2003
Last Updated
July 31, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00073710
Brief Title
Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Kidney Disease
Keywords
secondary hyperparathyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zemplar
Intervention Type
Procedure
Intervention Name(s)
42 Ca carbonate absorption via single tracer method
Intervention Type
Drug
Intervention Name(s)
Calcijex
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lund, M.D.
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

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

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