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.

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00150540

Purpose

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.

Condition	Intervention	Phase
Kidney Failure, Chronic	Drug: Lanthanum carbonate	Phase III

MedlinePlus related topics: Kidney Failure

Drug Information available for: Lanthanum Carbonate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Treatment emergent adverse events following up to 24 months of treatment

Secondary Outcome Measures:

Changes in pre-dialysis serum phosphate levels
Control of pre-dialysis serum phosphate levels
Plasma lanthanum levels

Estimated Enrollment:	93
Study Start Date:	October 2002
Study Completion Date:	January 2006

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication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

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	SPD405-309
Study First Received:	September 6, 2005
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00150540
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009