Conditions: End Stage Renal Disease
Keywords: Secondary HyperParaThyroidism (SHPT) Dialysis, End Stage Renal Disease (ESRD) KDOQI, Cinacalcet Clinical Trial, Amgen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 552
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.

Detailed description:

Arms:
arm 1: Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets. arm 2: Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on iPTH values.

Interventions: intervention 1: cinacalcet intervention 2: Standard of care
Intervention descriptions: intervention 1: Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. intervention 2: Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.

Protocol document: