A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chro… (NCT00257920) | Clinical Trial Compass
CompletedPhase 4
A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
United States41 participantsStarted 2006-06
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pro…
What they're measuring
1
Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)