Text Size

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
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

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  • Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
  • Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication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

No publications provided

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013