Back to resultsA Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
Primary Purpose
Secondary Hyperparathyroidism, End Stage Renal Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AMG 073
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMG 073
placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase
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
To evaluate the safety of AMG 073 compared with placebo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00037635
Brief Title
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AMG 073
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AMG 073
Intervention Description
30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally
Primary Outcome Measure Information:
Title
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 treatment)
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase
Time Frame
efficacy assessment phase (last 14 weeks of treatment)
Title
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 treatment)
Title
To evaluate the safety of AMG 073 compared with placebo.
Time Frame
entire study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16105056
Citation
Martin KJ, Juppner H, Sherrard DJ, Goodman WG, Kaplan MR, Nassar G, Campbell P, Curzi M, Charytan C, McCary LC, Guo MD, Turner SA, Bushinsky DA. First- and second-generation immunometric PTH assays during treatment of hyperparathyroidism with cinacalcet HCl. Kidney Int. 2005 Sep;68(3):1236-43. doi: 10.1111/j.1523-1755.2005.00517.x.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients
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