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Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5 | Clinical Trials | Clareo Health

TERMINATEDPHASE4

Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5

A Phase IV, Open-Label, Multi-Centre Trial Evaluating the Conversion From Standard Phosphate Binder Therapy to Fosrenol® in Chronic Kidney Disease Stage 5 Patients on Haemodialysis

NCT00452478•Shire

View on ClinicalTrials.gov

Summary

The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects greater than or equal to 18 years of age receiving a stable regimen of haemodialysis for chronic kidney disease (CKD) Stage 5 (defined as haemodialysis two or three times per week for at least two months prior to screening).
•Females of child bearing potential (FOCP) must be non-pregnant, non-lactating, have a negative serum beta human chorionic gonadotropin (HCG) test, and agree to comply with any applicable contraceptive requirements of the protocol.
•Subjects on a stable phosphate binder dose (defined as no change in medication or dosage for at least the one month prior to screening) with a serum phosphorus level between greater than 1.78 and less than or equal to 2.43 mmol/L (5.5 and 7.5 mg/dL).

Exclusion Criteria

•Subjects with a corrected serum calcium level less than 2.1 mmol/L (8.5 mg/dL).
•Subjects with an intact parathyroid hormone (iPTH) level greater than 500 pg/mL, or a history of previous parathyroidectomy within 12 months of screening.
•Subjects with any significant bowel obstruction, active inflammatory bowel disease, gastrointestinal (GI) motility disorders, abnormal or irregular bowel motion, or a history of major GI surgery within the last 6 months will be excluded.
•Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer hydrogen chloride (HCl) and calcium as a phosphate binder at the time of screening will be excluded.

Locations (14)

Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse

Feldkirch Tisis, Austria

Krankenhaus Elisabethinen/Dialysestation

Linz, Austria

Ziekenhuis Zuid Oost Limburg

Genk, Belgium

Frederica Sygehus

Fredericia, Denmark

Holbaek Sykehus

Holbæk, Denmark

Sygehus Viborg

Viborg, Denmark

Dialysezentrum Barmbek

Hamburg, Germany

Dialysezentrum Heilbronn

Heilbronn, Germany

Dialyse Leipzig

Leipzig, Germany

Nephrologisches Zentrum Emsland

Lingen, Germany

Key Dates

Start Date

May 22, 2007

Primary Completion Date

December 10, 2007

Completion Date

December 10, 2007

Last Updated

May 25, 2021

Enrollment

ACTUAL participants

Conditions

Kidney Diseases

Interventions

Lanthanum carbonate

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5

Inclusion Criteria

Exclusion Criteria

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