Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
1 other identifier
interventional
54
0 countries
N/A
Brief Summary
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2002
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 29, 2002
CompletedFirst Posted
Study publicly available on registry
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedResults Posted
Study results publicly available
March 1, 2011
CompletedMay 13, 2013
May 1, 2013
9 months
July 29, 2002
November 4, 2010
May 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Efficacy assessment phase (weeks 12-18)
Secondary Outcomes (1)
Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase
Baseline, efficacy assessment phase (weeks 12-18)
Study Arms (2)
cinacalcet (AMG 073)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients must have chronic renal insufficiency (pre-dialysis)
- Have below normal creatinine clearance
- Have elevated parathyroid hormone levels
You may not qualify if:
- Pregnant or nursing
- Heart attack in the last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
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.
PMID: 15983958RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 29, 2002
First Posted
August 1, 2002
Study Start
June 1, 2002
Primary Completion
March 1, 2003
Study Completion
August 1, 2003
Last Updated
May 13, 2013
Results First Posted
March 1, 2011
Record last verified: 2013-05