CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
Cinacalcet, active vitamin D analogueother
Likely dose
Not stated in 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/NCT01100723
NCT01100723Phase 4Completed
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Trial to Optimize Mineral Outcomes in End Stage Renal Disease (ESRD) Patients

University of Colorado, Denver·interventional·Posted Apr 9, 2010·Updated Jan 2, 2017

In Brief

A Phase 4 clinical trial evaluating Cinacalcet, active vitamin D analogue for Secondary Hyperparathyroidism and Chronic Kidney Disease. Completed, enrolled 92 participants across 1 site.

Detailed Summary

This trial is designed to determine if the use of a computer algorithm designed to optimize mineral outcomes in dialysis patients increases the number of patients achieving the desired target endpoints for calcium, phosphorus and parathyroid hormone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism, Chronic Kidney Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2010
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.2 years ago

Interventions

Cinacalcet, active vitamin D analogueother

Patients will have their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet will be dose increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.