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Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease - Article


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Biopsy of the Kidneys


Clinical Trial: Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

This study is not yet open for patient recruitment.
Verified by Amgen December 2005

Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00261950

Purpose

The purpose of this study is to evaluate the effects of cinacalcet on bone function and bone cells in patients with kidney disease who are receiving dialysis.
Condition Intervention Phase
Secondary Hyperparathyroidism
 Drug: Sensipar (Cinacalcet HCl)
Phase II

MedlinePlus related topics:  Parathyroid Disorders

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Bone Histomorphometry Assessment For Incident Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

Further study details as provided by Amgen:
Primary Outcomes: Change from baseline in bone turnover parameters
Secondary Outcomes: Changes in bone turnover parameters at one year; safety and tolerability of cinacalcet at one year.
Expected Total Enrollment:  85

Study start: January 2006;  Expected completion: July 2009
Last follow-up: December 2008;  Data entry closure: February 2009

Secondary HPT is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. Other problems from secondary HPT may include increases in blood levels of calcium and phosphorus. These may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis, muscle inflammation, itching, gangrene, or heart and lung problems.

The purpose of this study is to evaluate the effects of cinacalcet on bone function and bone cells in patients with kidney disease who are receiving dialysis. Cinacalcet has been used to decrease PTH levels in patients with secondary HPT.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria:

  • One biPTH determination obtained from the central laboratory must be >/= 160 pg/mL.
  • One serum calcium determination obtained from the central laboratory must be >/= 8.4 mg/dL (2.1 mmol/L).
  • One 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 for 1 month to 6 months before the date of informed consent.

Exclusion Criteria: 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®

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00261950

Amgen Call Center      866-572-6436 

More Information

Study ID Numbers:  20050104
Last Updated:  December 8, 2005
Record first received:  December 2, 2005
ClinicalTrials.gov Identifier:  NCT00261950
Health Authority: United States: Food and Drug Administration; EU: CHMP
ClinicalTrials.gov processed this record on 2006-01-10


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October 7, 2008



Page Updated: September 6, 2005
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