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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150566

Enrollment

460

Registered

2005-09-08

Start date

2004-02-09

Completion date

2005-10-08

Last updated

2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

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.

Interventions

DRUGLanthanum carbonate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment	4 & 8 weeks

Secondary

Measure	Time frame
Tolerability	8 weeks
Quality of Life	8 weeks
Subject/physician satisfaction and preference questionnaires	8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026