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 Development LLC

ClinicalTrials.gov Identifier:

NCT00150566

First received: September 6, 2005

Last updated: April 29, 2010

Last verified: April 2010

History of Changes

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:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Lanthanum Carbonate Lanthanum

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

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

No Contacts or Locations Provided

More Information

Additional Information:

FDA Recall Information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

FDA-approved Label This link exits the ClinicalTrials.gov site

Publications:

Mehrotra R, Martin KJ, Fishbane S, Sprague SM, Zeig S, Anger M; Fosrenol Overview Research Evaluation Study for Early Experience Study Group. Higher strength lanthanum carbonate provides serum phosphorus control with a low tablet burden and is preferred by patients and physicians: a multicenter study. Clin J Am Soc Nephrol. 2008 Sep;3(5):1437-45. Epub 2008 Jun 25.

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 May 23, 2013

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