NCT00110929

Brief Summary

The purpose of this research is to study the efficacy and safety of AMG 073 in patients with kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also have secondary hyperparathyroidism (HPT).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
850

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

November 1, 2002

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2005

Completed
Last Updated

April 23, 2010

Status Verified

April 1, 2010

First QC Date

May 16, 2005

Last Update Submit

April 22, 2010

Conditions

End Stage Renal Disease

Keywords

Sensipar®Secondary HPTMimpara®CinacalcetcalcimimeticEnd-Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

  • Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.

Secondary Outcomes (1)

  • Examine safety and tolerability of cinacalcet.

Interventions

AMG 073DRUG

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 (1)

  • Sprague SM, Evenepoel P, Curzi MP, Gonzalez MT, Husserl FE, Kopyt N, Sterling LR, Mix C, Wong G. Simultaneous control of PTH and CaxP Is sustained over three years of treatment with cinacalcet HCl. Clin J Am Soc Nephrol. 2009 Sep;4(9):1465-76. doi: 10.2215/CJN.06141108. Epub 2009 Aug 20.

    PMID: 19696213RESULT

Related Links

MeSH Terms

Conditions

Kidney Failure, Chronic

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 Symptoms

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2005

First Posted

May 17, 2005

Study Start

November 1, 2002

Last Updated

April 23, 2010

Record last verified: 2010-04