Clinical trial NCT00073710: Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
Official title: A Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease
Keywords: secondary hyperparathyroidism
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-12-04
Enrollment: 30
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: A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.


Eligibility criteria: 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.

Primary outcomes:
measure: The mean within subject difference in calcium absorption rates between treatment regimens will be analyzed using ANOVA appropriate for a two-period cross-over trial.
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Richard Lund, M.D.
role: PRINCIPAL_INVESTIGATOR
References: