NCT00113945

Brief Summary

The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) in subjects with ESRD receiving hemodialysis, on bio-intact parathyroid hormone (biPTH), corrected serum calcium, serum phosphorus, and calcium phosphorus product.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Status
completed

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

July 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2005

Completed
Last Updated

May 13, 2013

Status Verified

May 1, 2013

First QC Date

June 10, 2005

Last Update Submit

May 10, 2013

Conditions

End Stage Renal Disease

Keywords

End Stage Renal Disease (ESRD)secondary hyperparathyroidismhemodialysis, biPTHAMG 073, Amgen

Outcome Measures

Primary Outcomes (1)

  • Secondary hyperparathyroidism in people with kidney failure.

Secondary Outcomes (1)

  • Uncontrolled secondary hyperparathyroidism

Interventions

CinacalcetDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Block GA, Zeig S, Sugihara J, Chertow GM, Chi EM, Turner SA, Bushinsky DA; TARGET Investigators. Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism. Nephrol Dial Transplant. 2008 Jul;23(7):2311-8. doi: 10.1093/ndt/gfn026. Epub 2008 Feb 29.

    PMID: 18310602RESULT

  • Chertow GM, Lu ZJ, Xu X, Knight TG, Goodman WG, Bushinsky DA, Block GA. Self-reported symptoms in patients on hemodialysis with moderate to severe secondary hyperparathyroidism receiving combined therapy with cinacalcet and low-dose vitamin D sterols. Hemodial Int. 2012 Apr;16(2):188-97. doi: 10.1111/j.1542-4758.2011.00642.x.

    PMID: 22118402RESULT

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicHyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2005

First Posted

June 13, 2005

Study Start

July 1, 2003

Last Updated

May 13, 2013

Record last verified: 2013-05