12-month Study of AMG 073 in Renal Osteodystrophy

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2003-08-31

Brief Summary

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4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.

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Detailed Description

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Conditions

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Renal Osteodystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AMG 073

Group Type EXPERIMENTAL

AMG 073

Intervention Type DRUG

30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

Interventions

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AMG 073

30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

Intervention Type DRUG

Placebo

30 mg QD orally 50 mg QD orally 70 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age of greater
* Using effective contraceptive measures
* iPTH greater than or equal to 300 pg/mL
* Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
* Stable hemodialysis for 1 month prior to day 1

Exclusion Criteria

* Any unstable medical condition
* Pregnant or nursing women Recent parathyroidectomy
* Change in Vitamin D therapy
* Recent MI, Seizure, Malignancy, GI Disorder
* Inability to swallow tablets

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No