Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Brief Summary

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The purpose of this research is to study the efficacy and safety of AMG 073 in patients with kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also have secondary hyperparathyroidism (HPT).

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AMG 073

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Completed one of the qualifying studies (i.e.

Exclusion Criteria

, patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism \[HPT\]; in particular parathyroid hormone \[PTH\], calcium and phosphorus levels in blood associated with kidney failure) - Must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study Exclusion Criteria: - Pregnant or nursing females - Experienced a myocardial infarction within 3 months before day 1 - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No