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

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

NCT00037635

20000172

Details and patient eligibility

About

This 6 month long 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: 400 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: Triple Blind

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400 participants in 2 patient groups, including a placebo group

AMG 073

Experimental group

Treatment:

Drug: AMG 073

placebo

Placebo Comparator group

Treatment:

Drug: Placebo