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
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
1 other identifier
interventional
460
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2005
CompletedJune 8, 2021
June 1, 2021
1.7 years
September 6, 2005
June 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment
4 & 8 weeks
Secondary Outcomes (3)
Tolerability
8 weeks
Quality of Life
8 weeks
Subject/physician satisfaction and preference questionnaires
8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Related Publications (1)
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. doi: 10.2215/CJN.04741107. Epub 2008 Jun 25.
PMID: 18579668RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
February 9, 2004
Primary Completion
October 8, 2005
Study Completion
October 8, 2005
Last Updated
June 8, 2021
Record last verified: 2021-06