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Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride

NCT00844662 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

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 haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride.

Conditions

  • Chronic Kidney Failure

Interventions

DRUG

Fermagate

Film coated tablet 500mg

DRUG

Sevelamer hydrochloride

Tablet 800mg

Sponsors & Collaborators

  • Ineos Healthcare Limited

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer (Information at Ineos Healthcare Limited), Dr. · Ineos Healthcare Limited

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
2011-09-30
Completion
2011-10-31

Countries

  • United States
  • Belgium
  • Brazil
  • Bulgaria
  • Czechia
  • Estonia
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Mexico
  • Serbia
  • Slovakia
  • South Africa
  • United Kingdom

Study Locations

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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 NCT00844662 on ClinicalTrials.gov