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
ClinicalTrials.gov Identifier:
NCT00150540
First received: September 6, 2005
Last updated: September 13, 2007
Last verified: September 2007

September 6, 2005
September 13, 2007
October 2002
Not Provided
Treatment emergent adverse events following up to 24 months of treatment
Same as current
Complete list of historical versions of study NCT00150540 on ClinicalTrials.gov Archive Site
  • Changes in pre-dialysis serum phosphate levels
  • Control of pre-dialysis serum phosphate levels
  • Plasma lanthanum levels
Same as current
Not Provided
Not Provided
 
A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Failure, Chronic
Drug: Lanthanum carbonate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
January 2006
Not Provided

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  • Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
  • Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00150540
SPD405-309
Not Provided
Not Provided
Shire
Not Provided
Not Provided
Shire
September 2007

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