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Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate

NCT00841126 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2010-10-19

No results posted yet for this study

Summary

Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.

The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.

Conditions

  • Chronic Kidney Failure

Interventions

DRUG

Magnesium iron hydroxycarbonate

500 mg tablets, administered orally: initial dosage 500 or 1000 mg (total daily dose 1500 or 3000 mg) depending on serum phosphate concentration, titrated to a maximum DAILY dose of 9000 mg). The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 3000 mg.

DRUG

Lanthanum carbonate

750 mg chewable tablets, administered orally: initial dosage 750 mg up to 3-times daily (total daily dose 2250 mg), titrated to a maximum SINGLE dose of 1500 mg (DAILY dose 3750 mg). The total daily dose should be divided and taken with meals.

DRUG

Placebo

0 mg (500 mg-size) tablets, administered orally: The total daily dose should be divided and taken with meals. Any SINGLE dose should not exceed 6 tablets.

Sponsors & Collaborators

  • Ineos Healthcare Limited

    lead INDUSTRY

Principal Investigators

  • Information at Ineos Healthcare Limited (Chief Medical Officer) · INEOS Healthcare Ltd, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • France
  • Germany
  • Malta
  • New Zealand
  • Poland
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00841126 on ClinicalTrials.gov