Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease Secondary hyperparathyroidism
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 216
Healthy volunteers: no

Brief summary:
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Detailed description:
Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

Arms:
arm 1: Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). arm 2: Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)

Interventions: intervention 1: paricalcitol
Intervention descriptions: intervention 1: Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.

Protocol document: