Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

October 5, 2005

Last Updated Date

January 20, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Serum phosphorus levels at 8 weeks. [ Time Frame: 8 weeks ]

Original Primary Outcome Measures ^ICMJE

Serum phosphorus levels at 8 weeks.

Change History

Complete list of historical versions of study NCT00234702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PTH levels, calcium-phosphorus product. [ Time Frame: 8 weeks ]

Original Secondary Outcome Measures ^ICMJE

PTH levels, calcium-phosphorus product.

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease

Official Title ^ICMJE

A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels

Brief Summary

Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Diseases

Intervention ^ICMJE

Drug: Lanthanum carbonate
Drug: Placebo

Study Arms / Comparison Groups

Publications *

Sprague SM, Abboud H, Qiu P, Dauphin M, Zhang P, Finn W. Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial. Clin J Am Soc Nephrol. 2009 Jan;4(1):178-85. Epub 2008 Dec 3.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Under a physician's care for CKD for > 2 months and are not expected to begin dialysis for 4 months
Screening estimated GFR of 15-59 mL/1.73 m2
Serum phosphorus >= 4.7 mg/d following washout

Exclusion Criteria:

Requiring treatment with cinacalcet HCI or compounds containing phosphate, aluminum, calcium or magnesium
Rapidly progressing glomerulonephritis
Cirrhosis or other clinically significant liver diseases
Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI bleed

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

United States

Administrative Information

NCT ID ^ICMJE

NCT00234702

Responsible Party

Timothy Whitaker, M.D., Shire

Study ID Numbers ^ICMJE

SPD405-206

Study Sponsor ^ICMJE

Shire Pharmaceutical Development

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dr. William F Finn

The University of North Carolina, Chapel Hill

Information Provided By

Shire Pharmaceutical Development

Verification Date

January 2009

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