Inclusion 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.
