Skip to main content
OpenTrials
Completed

NCT Number: NCT00160121

Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease

The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ESRD who currently require treatment for hyperphosphatemia

Exclusion criteria

  • Female patient who is pregnant or lactating
  • Patient has used any investigational product within 30 days of screening

Treatment and study plan

Lanthanum carbonate

Drug

Primary outcomes

  1. Pre-dialysis serum phosphorus levels at 12 weeks

    Time frame: Week 12

  2. Patient satisfaction questionnaire at 12 weeks

    Time frame: Week 12

    7 question patient satisfaction questionnaire for participants to respond to how strongly they agree or disagree with their experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.

  3. Physician satisfaction questionnaire at 12 weeks

    Time frame: Week 12

    6 question physician satisfaction questionnaire for physicians to respond to how strongly they agree or disagree with their patient's experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.

  4. Patient preference questionnaire at 12 weeks

    Time frame: Week 12

    6 question patient preference questionnaire for participants to respond to whether they preferred the medication they received during this clinical trial or their previous medication.

  5. Physician preference questionnaire at 12 weeks

    Time frame: Week 12

    7 question physician preference questionnaire for physicians to respond to whether they preferred the medication administered during this clinical trial or their patient's previous medication.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase IV, Open-Label, Multi-Center Trial Evaluating the Efficacy of Fosrenol Compared to Existing Therapy in Adults With End Stage Renal Disease Treated for Hyperphosphatemia

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.