Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

January 22, 2009 updated by: Amgen

A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis

Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and Women greater than or equal to 18 years of age
  • Using effective contraceptive measures
  • Mean iPTH during screening of greater than or equal to 300 pg/mL
  • Mean calcium during screening of greater than or equal to 8.4 mg/dL
  • Stable on hemodialysis

Exclusion Criteria:

  • Unstable medical conditions
  • Parathyroidectomy within 3 months
  • Change in Vitamin D therapy
  • Receiving antidepressants
  • Experienced an MI within 3 months
  • Inability to swallow tablets
  • Previously received AMG 073

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
30 mg placebo once daily orally 60 mg placebo once daily orally 90 mg placebo once daily orally 120 mg placebo once daily orally 180 mg placebo once daily orally
Experimental: AMG 073
Drug: AMG 073
30 mg AMG 073 once daily 60 mg AMG 073 once daily 90 mg AMG 073 once daily 120 mg AMG 073 once daily 180 mg AMG 073 once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.
Time Frame: Efficacy Assessment Phase - last 14 weeks of study
Efficacy Assessment Phase - last 14 weeks of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in iPTH of >= during the efficacy assessment phase
Time Frame: Efficacy Assessment Phase - last 14 weeks of study
Efficacy Assessment Phase - last 14 weeks of study
To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in calcium x phosphorus (Ca x P) during the efficacy assessment phase
Time Frame: Efficacy Assessment Phase - last 14 weeks of study
Efficacy Assessment Phase - last 14 weeks of study
To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase
Time Frame: Efficacy Assessment Phase - last 14 weeks of study
Efficacy Assessment Phase - last 14 weeks of study
To evaluate the safety of AMG 073 compared with placebo.
Time Frame: Entire study - 26 weeks
Entire study - 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2009

Last Update Submitted That Met QC Criteria

January 22, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20000183 (Ethical approval)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperparathyroidism

Clinical Trials on AMG 073

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe