Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
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.
This is a multi-center, prospective, open label, one arm, phase IV study designed to
 demonstrate paricalcitol efficacy and safety in the treatment of moderate to severe secondary
 hyperparathyroidism in calcitriol resistant participants on dialysis.

 Following screening, participants began an 8-week controlled calcitriol therapy period.
 Participants whose parathyroid hormone (PTH) levels decreased were to be discontinued from
 the study. Those whose PTH levels did not decrease began paricalcitol therapy using a dose
 calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol was administered
 intravenously at anytime during the subjects' dialysis. The paricalcitol dose was to be
 titrated every 2 weeks until iPTH was reduced or up to 4 months, after which it was to be
 adjusted monthly for 1 year based on serum PTH, calcium, phosphorus, and albumin
 measurements.
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.