Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00150566
First received: September 6, 2005
Last updated: April 29, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Lanthanum carbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIIb, Multi-center, Two-Cohort, Randomized Study, With an Open-Label Run-In and a Long-Term Extensions Phase, Assessing an Extended Dose Range of Lanthanum Carbonate in End Stage Renal Disease Subjects Receiving Hemodialysis

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment [ Time Frame: 4 & 8 weeks ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 8 weeks ]
  • Quality of Life [ Time Frame: 8 weeks ]
  • Subject/physician satisfaction and preference questionnaires [ Time Frame: 8 weeks ]

Estimated Enrollment: 460
Study Start Date: February 2004
Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with ESRD who currently require treatment for hyperphosphatemia
  • Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study

Exclusion Criteria:

  • Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder
  • Hypocalcaemia
  • Treatment-naive to any phosphate binder with a serum phosphorus < 5.5 mg/dL
  • Any significant gastrointestinal surgery or gastrointestinal disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00150566     History of Changes
Other Study ID Numbers: SPD405-312
Study First Received: September 6, 2005
Last Updated: April 29, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014