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

NCT ID: NCT00160121

Last Updated: 2021-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-10

Study Completion Date

2005-12-13

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Failure, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lanthanum carbonate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

References

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Wilson RJ, Keith MS, Preston P, Copley JB. The real-world dose-relativity of sevelamer hydrochloride and lanthanum carbonate monotherapy in patients with end-stage renal disease. Adv Ther. 2013 Dec;30(12):1100-10. doi: 10.1007/s12325-013-0077-5. Epub 2013 Dec 5.

Reference Type RESULT
PMID: 24307220 (View on PubMed)

Keith MS, Wilson RJ, Preston P, Copley JB. Cost-minimization analysis of lanthanum carbonate versus sevelamer hydrochloride in US patients with end-stage renal disease. Clin Ther. 2014 Sep 1;36(9):1276-86. doi: 10.1016/j.clinthera.2014.06.036. Epub 2014 Jul 26.

Reference Type RESULT
PMID: 25069799 (View on PubMed)

Related Links

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Other Identifiers

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SPD405-401

Identifier Type: -

Identifier Source: org_study_id

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