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

Primary Purpose

Chronic Kidney Disease, Stage 5, Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zemplar® injection
Hectorol® injection
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease, Stage 5 focused on measuring Stage 5 Chronic Kidney Disease (CKD)

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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)
Calcium Absorption Fraction obtained at the end of Period 1 & Period 2

Secondary Outcome Measures

Calcium Absorption Fractions Analyzed by Mixed Model
Calcium Absorption Fraction obtained at the end of Period 1 & Period 2

Full Information

First Posted
November 22, 2005
Last Updated
December 22, 2009
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00257920
Brief Title
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Stage 5, Secondary Hyperparathyroidism
Keywords
Stage 5 Chronic Kidney Disease (CKD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zemplar® injection
Other Intervention Name(s)
ABT-358, paricalcitol, Zemplar
Intervention Description
6 mcg QOD
Intervention Type
Drug
Intervention Name(s)
Hectorol® injection
Other Intervention Name(s)
Hectorol®
Intervention Description
3.6 mcg QOD
Primary Outcome Measure Information:
Title
Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)
Description
Calcium Absorption Fraction obtained at the end of Period 1 & Period 2
Time Frame
42 Days
Secondary Outcome Measure Information:
Title
Calcium Absorption Fractions Analyzed by Mixed Model
Description
Calcium Absorption Fraction obtained at the end of Period 1 & Period 2
Time Frame
42 Days

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 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.
Facility Information:
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

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

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