A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis

Amgen

Status and phase: Completed; Phase 3

Conditions: End Stage Renal Disease; Secondary Hyperparathyroidism

Treatments: Drug: AMG 073; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00042653

20000188

Details and patient eligibility

About

This 6 month study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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380 participants in 2 patient groups, including a placebo group

AMG 073

Experimental group

Description:

AMG 073

Treatment:

Drug: AMG 073

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo