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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150566
• Other study ID #: SPD405-312
• Status: Completed
• Phase: Phase 3
• Start date: February 9, 2004
• Est. completion date: October 8, 2005

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: October 8, 2005
• Est. primary completion date: October 8, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Lanthanum carbonate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

References & 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 b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment		4 & 8 weeks
Secondary	Tolerability		8 weeks
Secondary	Quality of Life		8 weeks
Secondary	Subject/physician satisfaction and preference questionnaires		8 weeks

External Links

•   FDA Recall Information
•   FDA-approved Label