Status:
COMPLETED
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
Lead Sponsor:
Abbott
Conditions:
Chronic Kidney Disease, Stage 5
Secondary Hyperparathyroidism
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00257920
Start Date
June 1 2006
Last Update
December 24 2009
Active Locations (2)
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1
Bellevue, Nebraska, United States, 68123
2
Omaha, Nebraska, United States, 68131