At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 110 enrolled

Drug / intervention

Sensipar (Cinacalcet HCl)drug

Likely dose

Sensipar (Cinacalcet HCl) 30 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00261950

NCT00261950Phase 2Completed

Compare CT.gov

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

Amgen·interventional·Posted Dec 6, 2005·Updated Jul 21, 2014

In Brief

A Phase 2 clinical trial evaluating Sensipar (Cinacalcet HCl) for Secondary Hyperparathyroidism. Completed, enrolled 110 participants across 55 sites in 12 countries.

Detailed Summary

The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSecondary Hyperparathyroidism

CountriesBelgium, Czechia, Hungary, Italy, North Macedonia, Poland, Portugal, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States

Collaborators--

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedDec 2005

Enrollment StartMay 2006

Primary CompletionMay 2011

TodayJul 2026

First PostedDec 6, 2005

Enrollment StartMay 1, 2006

Primary CompletionMay 1, 2011

TodayJul 2, 2026

Enrollment to primary: 5 yearsPosted 20.6 years ago

Interventions

Sensipar (Cinacalcet HCl)drug

All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.