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.
