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

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

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

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.