Status:
COMPLETED
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Lead Sponsor:
Amgen
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
Detailed Description
Secondary hyperparathyroidism (HPT) is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result of...
Eligibility Criteria
Inclusion
- Subjects will be eligible for the study if they meet all of the following criteria:
- One Intact Parathyroid Hormone (iPTH) determination obtained from the central laboratory must be \>/= 300 pg/mL.
- One serum calcium determination obtained from the central laboratory must be \>/= 8.4 mg/dL (2.1 mmol/L).
- One Bone Alkaline Phosphatase (BALP) determination obtained from the central laboratory must be \>/= 20.9 ng/mL.
- Positive histologic confirmation of high bone turnover disease as assessed by the central bone histology center.
- Treated with dialysis \>/= 1 month before the date of informed consent.
Exclusion
- Subjects will be ineligible for the study if they:
- Have an unstable medical condition in the judgment of the investigator.
- Are pregnant or nursing women.
- Had a parathyroidectomy in the 3 months before the date of informed consent.
- For subjects prescribed vitamin D, have received vitamin D therapy for less than 30 days before day 1 or required a change in vitamin D brand or dose level within 30 days before day 1.
- Ever received therapy with Sensipar®/Mimpara®
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00261950
Start Date
May 1 2006
End Date
May 1 2011
Last Update
July 21 2014
Active Locations (55)
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1
Research Site
Phoenix, Arizona, United States, 85012
2
Research Site
Los Angeles, California, United States, 90095
3
Research Site
Denver, Colorado, United States, 80220
4
Research Site
New Haven, Connecticut, United States, 06511