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

June 2, 2021 updated by: Shire

A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

456

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
Time Frame: Week 3 and Week 5
Week 3 and Week 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment emergent adverse events
Time Frame: Throughout the study period of approximately 20 months.
Throughout the study period of approximately 20 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2004

Primary Completion (Actual)

January 12, 2006

Study Completion (Actual)

January 12, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD405-313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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