Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

May 9, 2013 updated by: Amgen

A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

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:

  • Patients must have chronic renal insufficiency (pre-dialysis)
  • Have below normal creatinine clearance
  • Have elevated parathyroid hormone levels

Exclusion Criteria:

  • Pregnant or nursing
  • Heart attack in the last 3 months.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: cinacalcet (AMG 073)
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
Experimental: cinacalcet (AMG 073)
Drug: cinacalcet (AMG 073)
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
Time Frame: Efficacy assessment phase (weeks 12-18)
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
Efficacy assessment phase (weeks 12-18)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
Time Frame: Baseline, efficacy assessment phase (weeks 12-18)
Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase
Baseline, efficacy assessment phase (weeks 12-18)

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.

General Publications

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

June 1, 2002

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

July 29, 2002

First Submitted That Met QC Criteria

July 31, 2002

First Posted (Estimate)

August 1, 2002

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20010239

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.

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