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

Phase 3

Completed

• Conditions: Kidney Failure, Chronic

• Registration Number: NCT00151931
• Lead Sponsor: Shire

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05-11
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2006-01-12
• Study Completion: 2006-01-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	Throughout the study period of approximately 20 months.