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

NCT ID: NCT00073710

Last Updated: 2006-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30

Brief Summary

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

Conditions

Secondary Hyperparathyroidism; Chronic Kidney Disease

Keywords

secondary hyperparathyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Zemplar

Intervention Type: DRUG

42 Ca carbonate absorption via single tracer method

Intervention Type: PROCEDURE

Calcijex

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Principal Investigators

Richard Lund, M.D.

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Creighton University

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

M01-375

Identifier Type: -

Identifier Source: org_study_id