Overview

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

Status:
Completed
Trial end date:
2006-01-12
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shire
Criteria
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