Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
Condition: Secondary Hyperparathyroidism; Dialysis
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Calcitriol; Paricalcitol
Intervention description: Initial doses determined according to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guideline (Am J Kidney Dis 2003;42(4)Suppl 3:S1-S201). During therapy, calcitriol dose may be modified by 0.5 - 1 mcg at 2- to 4-week intervals.; Dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol will be administered intravenously after the participants' dialysis. The paricalcitol dose will be titrated every 2 weeks until iPTH presents a reduction or up to 4 months, after which it will be adjusted monthly based on serum PTH, calcium, phosphorus and albumin measurements. Dosing may be modified by 2-4 mcg increments at 2- to 4-week intervals.
Intervention MeSH terms: Calcitriol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dialysis; Calcitriol Resistant; Secondary Hyperparathyroidism

Summary:

      The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in
      participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing
      hemodialysis who are resistant to treatment with calcitriol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants > 18 years of age, with chronic kidney disease (CKD)
             stage V;

          -  Participants with diagnosis of calcitriol resistance defined as: Episodes of
             hypercalcemia and/or hyperphosphatemia (defined as an episode of calcium or phosphorus
             above Upper Limit of Normal or documented by medical history stating that the
             treatment with calcitriol was discontinued due to hypercalcemia and/or
             hyperphosphatemia) that precludes treatment continuation and/or persistent PTH above
             600pg/mL during the calcitriol therapy;

          -  PTH value at screening visit between 600 pg/mL and 2,000 pg/mL;

          -  Stable clinical conditions;

          -  Participant has voluntarily consented to participate in the study, by signing and
             dating an informed consent form, approved by an Institutional Review Board
             (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been
             explained and all his questions about the study have been elucidated. The informed
             consent must be signed before any study-specific procedures are performed.

        Exclusion Criteria:

          -  Previous parathyroidectomy;

          -  Presence of hypercalcemia (corrected Ca > 10.5 mg/dL) and/or hyperphosphatemia (P >
             6.0 mg/dL) and/or Ca x P product > 60, at screening visit (corrected Ca calculated by:
             [4 - participant's serum albumin (g/dL)] x 0.8 + participant's serum Ca value);

          -  Severe and/or unstable clinical conditions, e.g., congestive heart failure, advanced
             cancer, advanced HIV disease, severe endocrinopathies, uncompensated diabetes
             mellitus, life-threatening cardiac arrhythmias, etc;

          -  Abnormal liver tests (> 1.5 times above upper limit of normal);

          -  Pregnant or breast-feeding women;

          -  Evidence of vitamin D toxicity;

          -  Known hypersensitivity to any study drug components.