Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Primary Purpose
Secondary Hyperparathyroidism, Chronic Renal Insufficiency
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cinacalcet (AMG 073)
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cinacalcet (AMG 073)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
Secondary Outcome Measures
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00042432
Brief Title
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Official Title
A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Renal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cinacalcet (AMG 073)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
cinacalcet (AMG 073)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase
Description
Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase
Time Frame
Efficacy assessment phase (weeks 12-18)
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
Description
Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase
Time Frame
Baseline, efficacy assessment phase (weeks 12-18)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
15983958
Citation
Charytan C, Coburn JW, Chonchol M, Herman J, Lien YH, Liu W, Klassen PS, McCary LC, Pichette V. Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis. Am J Kidney Dis. 2005 Jul;46(1):58-67. doi: 10.1053/j.ajkd.2005.04.013.
Results Reference
result
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://www.sensipar.com/
Description
FDA-approved Drug Labeling
Learn more about this trial
Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
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