Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis

A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151931

Enrollment

456

Registered

2005-09-09

Start date

2004-05-11

Completion date

2006-01-12

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 assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate

Interventions

DRUGLanthanum carbonate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males and females of childbearing potential agree to take adequate precautions to prevent contraception * Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study * Patient requires treatment for hyperphosphataemia

Exclusion criteria

* Pregnant or lactating women * Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium * Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma * Patients who are HIV+ * Patients with any significant gastrointestinal surgery or disorders

Design outcomes

Primary

Measure	Time frame
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5	Week 3 and Week 5

Secondary

Measure	Time frame
Treatment emergent adverse events	Throughout the study period of approximately 20 months.

Outcome results

None listed

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