A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
Condition: Chronic Kidney Disease, Stage 5; Secondary Hyperparathyroidism
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Zemplar® injection; Hectorol® injection
Intervention description: 6 mcg QOD; 3.6 mcg QOD
Intervention MeSH terms: 1 alpha-hydroxyergocalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Stage 5 Chronic Kidney Disease (CKD)

Summary:

      The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol®
      Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on
      hemodialysis.
    

Eligibility criteria:

        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.