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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160121

Enrollment

2500

Registered

2005-09-12

Start date

2005-01-10

Completion date

2005-12-13

Last updated

2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

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.

Interventions

DRUGLanthanum carbonate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pre-dialysis serum phosphorus levels at 12 weeks	Week 12	—
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.
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.
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.
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026