Status:
COMPLETED
Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
Lead Sponsor:
Abbott
Conditions:
Secondary Hyperparathyroidism
Chronic Kidney Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00073710
Start Date
September 1 2004
Last Update
August 2 2006
Active Locations (1)
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1
Creighton University
Omaha, Nebraska, United States, 68131