Clinical trial NCT00257920: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease, Stage 5
Secondary Hyperparathyroidism
Keywords: Stage 5 Chronic Kidney Disease (CKD)
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-11-24
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)
timeFrame: 42 Days
Secondary outcomes:
measure: Calcium Absorption Fractions Analyzed by Mixed Model
timeFrame: 42 Days
Other outcomes:
Locations:
city: Bellevue
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
Study officials:
References: