Head to Head Study Against Sevelamer Hydrochloride

This study has been completed.

Study NCT00441545 Information provided by Shire Pharmaceutical Development

First Received: February 27, 2007 Last Updated: October 1, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment
Condition:	Chronic Kidney Disease, Stage 5
Interventions:	Drug: Fosrenol (Lanthanum Carbonate) Drug: Sevelamer hydrochloride

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	No text entered.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	182
Age [units: participants]
<=18 years	0
Between 18 and 65 years	140
>=65 years	42
Age [units: years] Mean ± Standard Deviation	55.5 ± 13.10
Gender [units: participants]
Female	80
Male	102
Region of Enrollment [units: participants]
United States	139
Puerto Rico	1
Germany	41
United Kingdom	1

Outcome Measures

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1. Primary:

Change From Baseline in Serum Phosphorus Levels at 4 Weeks [ 4 weeks ]

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2. Secondary:

Change From Baseline in Serum Calcium Levels at 4 Weeks [ 4 weeks ]

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3. Secondary:

Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks [ Baseline and 4 weeks ]

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4. Secondary:

Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks [ 4 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Timothy Whitaker, MD
Organization: Shire
e-mail: twhitaker@shire.com

No publications provided

Responsible Party:	Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD405-319
Study First Received:	February 27, 2007
Results First Received:	June 29, 2009
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00441545 History of Changes
Health Authority:	United States: Food and Drug Administration