Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073710
• Other study ID #: M01-375
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2003
• Last updated: July 31, 2006
• Start date: September 2004

Study information

• Verified date: July 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• Zemplar

Procedure:
• 42 Ca carbonate absorption via single tracer method

Drug:
• Calcijex

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.