CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 182 enrolled
Drug / intervention
Fosrenol (Lanthanum Carbonate) +1 moredrug
Likely dose
Fosrenol (Lanthanum Carbonate) 2250mgfrom 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/NCT00441545
NCT00441545Phase 3Completed
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A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease

Shire·interventional·Posted Mar 1, 2007·Updated Jun 11, 2021

In Brief

A Phase 3 clinical trial evaluating Fosrenol (Lanthanum Carbonate) and Sevelamer hydrochloride for Chronic Kidney Disease, Stage 5. Completed, enrolled 182 participants across 44 sites in 4 countries.

Detailed Summary

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Stage 5
CountriesGermany, Puerto Rico, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2007
Enrollment StartJan 5, 2007
Primary CompletionJul 31, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.3 years ago

Interventions

Fosrenol (Lanthanum Carbonate)drug

The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.

Sevelamer hydrochloridedrug

The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.