A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.

This study has been completed.

Sponsor:

Information provided by:

Shire Development LLC

ClinicalTrials.gov Identifier:

NCT00150540

First received: September 6, 2005

Last updated: September 13, 2007

Last verified: September 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	September 6, 2005
Last Updated Date	September 13, 2007
Start Date ^ICMJE	October 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 6, 2005)	Treatment emergent adverse events following up to 24 months of treatment
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00150540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 6, 2005)	Changes in pre-dialysis serum phosphate levels Control of pre-dialysis serum phosphate levels Plasma lanthanum levels
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
Official Title ^ICMJE	A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.
Brief Summary	The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Kidney Failure, Chronic
Intervention ^ICMJE	Drug: Lanthanum carbonate
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	93
Completion Date	January 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate Patients must continue to require treatment with a phosphate binder for hyperphosphatemia male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter Exclusion Criteria: Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication Pregnant or lactating women
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00150540
Other Study ID Numbers ^ICMJE	SPD405-309
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Shire Development LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shire Development LLC
Verification Date	September 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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