Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
Condition: Secondary Hyperparathyroidism; Renal Insufficiency, Chronic; Parathyroid Hormone; Hemodialysis; Hypercalcemia
MeSH terms: Neoplasm Metastasis; Renal Insufficiency; Renal Insufficiency, Chronic; Hypercalcemia; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Zemplar (paricalcitol)
Intervention description: Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.
Intervention MeSH terms: Ergocalciferols
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to observe the effectiveness and safety of the use of a low
      initial dose regime (iPTH/100) in chronic kidney disease patients with secondary
      hyperparathyroidism (PTH>300pg/mL) and that require dialysis at least 3 times per week.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients >=18 years old with secondary hyperparathyroidism (PTH>300pg/mL, measured in
             the last 2 weeks).

          -  Patients on hemodialysis who require starting therapy with IV paricalcitol (de novo).

          -  Patients attending 3 hemodialysis sessions per week.

          -  Patients signing the informed consent approved by the Ethics Committee. If any
             individual is not capable of giving his/her consent, it can be obtained from a next of
             kin or from his/her legal representative, according to local laws and regulations.

          -  The decision to initiate treatment is upon the investigator and the decision to treat
             patients with IV paricalcitol must not be based on the inclusion of the patient in the
             study or any other way. The decision to treat a patient with IV paricalcitol will be
             taken prior to asking the patient to participate in the study.

        Exclusion Criteria:

          -  Patients with any concomitant clinical condition that, according to the investigator's
             opinion, might impede an adequate assessment of the treatment response.

          -  Patients with severe hyperparathyroidism (PTH>3000pg/mL).

          -  Patients with a serum calcium level greater or equal to 10.5mg/dL, phosphorus greater
             or equal to 6.5mg/dL, or those with Calcium X Phosphorus product 65 (measured at least
             2 weeks before the study).

          -  Patients with neoplastic disease.

          -  Pregnant or lactating women.

          -  Known hypersensitivity and/or toxicity to vitamin D metabolites and/or to other
             ingredients of the product.

          -  Having participated in another study with an investigational product or device within
             the previous 30 days or having planned to participate in another study within the same
             period of time as the actual study.

          -  Use of vitamin D analogue during the last 3 months prior to the inclusion to this
             study.