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

This study has been terminated.

(This study was stopped by the sponsor based on a non-safety related corporate decision)

Sponsor:

Information provided by:

Shire Development LLC

ClinicalTrials.gov Identifier:

NCT00452478

First received: March 23, 2007

Last updated: December 18, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

March 23, 2007

Last Updated Date

December 18, 2007

Start Date ^ICMJE

May 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78 mmol/L (5.5 mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78mmol/L (5.5mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy.

Change History

Complete list of historical versions of study NCT00452478 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol [ Time Frame: at Week 2 compared to baseline ] [ Designated as safety issue: No ]
Biochemical and haematological parameters [ Time Frame: measured throughout the study ] [ Designated as safety issue: No ]
Assess safety & tolerability [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The maintenance of mean serum phosphorus levels following treatment with 2250mg/day of Fosrenol at Week 2 compared to baseline.Biochemical and haematological parameters will be measured throughout the study.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Kidney Diseases

Intervention ^ICMJE

Drug: Lanthanum carbonate

2250mg/day starting dose of lanthanum carbonate administered orally, in divided doses, with meals (500mg 750mg and 1000mg strengths)for 2 weeks; dose titration will occur based on serum phosphorus results not to exceed 3000mg/day.

Other Name: FOSRENOL

Study Arm (s)

Experimental: 1

Intervention: Drug: Lanthanum carbonate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Belgium, Denmark, Germany, Italy, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00452478

Other Study ID Numbers ^ICMJE

SPD405-403

Has Data Monitoring Committee

Not Provided

Responsible Party

Timothy Whitaker, M.D., Shire Pharmaceutical

Study Sponsor ^ICMJE

Shire Development LLC

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mario Cozzolino, MD, PhD

Renal Physician

Information Provided By

Shire Development LLC

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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