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

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanthanum carbonate

Drug

Primary outcomes

Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5

Time frame: Week 3 and Week 5

Secondary outcomes

Treatment emergent adverse events

Time frame: Throughout the study period of approximately 20 months.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Sep 9, 2005
Registry last updated: Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed