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

Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00160121
Collaborator
(none)
2,500
Enrollment
11.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lanthanum carbonate
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 10, 2005
Actual Primary Completion Date :
Dec 13, 2005
Actual Study Completion Date :
Dec 13, 2005

Outcome Measures

Primary Outcome Measures

  1. Pre-dialysis serum phosphorus levels at 12 weeks [Week 12]

  2. Patient satisfaction questionnaire at 12 weeks [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shire

Investigators

  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Shire
ClinicalTrials.gov Identifier:
NCT00160121
Other Study ID Numbers:
  • SPD405-401
First Posted:
Sep 12, 2005
Last Update Posted:
Jul 2, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency

Study Results

No Results Posted as of Jul 2, 2021