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

This study has been completed.

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00261950

First received: December 2, 2005

Last updated: January 18, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 2, 2005

Last Updated Date

January 18, 2012

Start Date ^ICMJE

January 2006

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in bone turnover parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in bone turnover parameters

Change History

Complete list of historical versions of study NCT00261950 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in bone turnover parameters at one year; safety and tolerability of cinacalcet at one year. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Changes in bone turnover parameters at one year; safety and tolerability of cinacalcet at one year.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Secondary Hyperparathyroidism

Intervention ^ICMJE

Drug: Sensipar (Cinacalcet HCl)

30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily

Study Arm (s)

Experimental: I

100% of subjects on study (85 subjects)

Intervention: Drug: Sensipar (Cinacalcet HCl)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

110

Completion Date

May 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

One 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 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 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®

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Czech Republic, Hungary, Italy, Macedonia, The Former Yugoslav Republic of, Poland, Portugal, Spain, Switzerland, Turkey, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00261950

Other Study ID Numbers ^ICMJE

20050104, BONAFIDE Study

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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