Head to Head Study Against Sevelamer Hydrochloride - Tabular View

Tracking Information

First Received Date ^ICMJE

February 27, 2007

Last Updated Date

October 1, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change From Baseline in Serum Phosphorus Levels at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in serum phosphorus levels at the end of each treatment period.

Change History

Complete list of historical versions of study NCT00441545 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change From Baseline in Serum Calcium Levels at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Serum phosphorus, calcium and PTH at each visit.

Descriptive Information

Brief Title ^ICMJE

Head to Head Study Against Sevelamer Hydrochloride

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Kidney Disease, Stage 5

Intervention ^ICMJE

Drug: Fosrenol (Lanthanum Carbonate)
Drug: Sevelamer hydrochloride

Study Arms / Comparison Groups

Experimental: Fosrenol (Lanthanum carbonate)
Active Comparator: Sevelamer hydrochloride

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

182

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults with end stage renal disease who are receiving dialysis

Exclusion Criteria:

Subjects with significant gastrointestinal disorders
Subjects who are pregnant or nursing
Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
Subjects who are HIV positive
Subjects with clinical significant liver disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany, Puerto Rico, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00441545

Responsible Party

Timothy Whitaker, M.D., Shire Pharmaceutical

Study ID Numbers ^ICMJE

SPD405-319

Study Sponsor ^ICMJE

Shire Pharmaceutical Development

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Stuart Sprague, D.O.

Evanston Northwestern Hospital

Information Provided By

Shire Pharmaceutical Development

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP