A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00257920
First received: November 22, 2005
Last updated: December 22, 2009
Last verified: December 2009
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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:
|
| 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 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 May 23, 2013