Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis

NCT ID: NCT00151931

Last Updated: 2021-06-08

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

PHASE3

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-11

Study Completion Date

2006-01-12

Brief Summary

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The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate

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

* Males and females of childbearing potential agree to take adequate precautions to prevent contraception
* Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
* Patient requires treatment for hyperphosphataemia

Exclusion Criteria

* Pregnant or lactating women
* Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
* Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
* Patients who are HIV+
* Patients with any significant gastrointestinal surgery or disorders
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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Hutchison AJ, Laville M; SPD405-313 Lanthanum Study Group. Switching to lanthanum carbonate monotherapy provides effective phosphate control with a low tablet burden. Nephrol Dial Transplant. 2008 Nov;23(11):3677-84. doi: 10.1093/ndt/gfn310. Epub 2008 Jun 24.

Reference Type BACKGROUND
PMID: 18577536 (View on PubMed)

Related Links

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Other Identifiers

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SPD405-313

Identifier Type: -

Identifier Source: org_study_id

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