NCT00094484

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

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

October 1, 2004

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2004

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

First QC Date

October 19, 2004

Last Update Submit

May 6, 2013

Conditions

Kidney DiseaseChronic Kidney Disease

Keywords

Sensipar®Mimpara®CinacalcetCalcimimeticChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks

Secondary Outcomes (2)

  • Changes in iPTH at 32 weeks.

  • Safety and tolerability of cinacalcet at 32 weeks.

Interventions

Cinacalcet HClDRUG

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)

  • Chonchol M, Locatelli F, Abboud HE, Charytan C, de Francisco AL, Jolly S, Kaplan M, Roger SD, Sarkar S, Albizem MB, Mix TC, Kubo Y, Block GA. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet HCl in participants with CKD not receiving dialysis. Am J Kidney Dis. 2009 Feb;53(2):197-207. doi: 10.1053/j.ajkd.2008.09.021. Epub 2008 Dec 24.

    PMID: 19110359RESULT

Related Links

MeSH Terms

Conditions

Kidney DiseasesRenal Insufficiency, Chronic

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic 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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 19, 2004

First Posted

October 20, 2004

Study Start

October 1, 2004

Last Updated

May 8, 2013

Record last verified: 2013-05