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

Shire

Status and phase: Completed; Phase 3

Conditions: Kidney Failure, Chronic

Treatments: Drug: Lanthanum carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151931

SPD405-313

Details and patient eligibility

About

The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)