A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

This study is currently recruiting participants.

Verified by Genzyme, August 2009

First Received: January 29, 2009 Last Updated: August 6, 2009 History of Changes

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00833768

Purpose

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

Condition	Intervention	Phase
Chronic Kidney Disease Hyperphosphatemia	Drug: Sevelamer carbonate Drug: Placebo for sevelamer carbonate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

Resource links provided by NLM:

Drug Information available for: Sevelamer Sevelamer hydrochloride Sevelamer carbonate

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:

To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum total cholesterol and low density lipoprotein (LDL) cholesterol [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	207
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Sevelamer carbonate 800mg tablets to be taken orally with meals three times per day
2: Placebo Comparator	Drug: Placebo for sevelamer carbonate Placebo tablets to be taken orally with meals three times per day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable.

Exclusion Criteria:

1. Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833768

Contacts

Contact: Medical Information	800-745-4447	medinfo@genzyme.com
Contact: Medical Information	617-252-7832	medinfo@genzyme.com

Show 36 Study Locations

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	SVCARB00606, Eudra CT: 2007-003885-16
Study First Received:	January 29, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00833768 History of Changes
Health Authority:	Germany: Bundestinstiut fur Arzneimittel und Medizinprodukte (BfArM); Sweden: Medicines Products Agency (MPA); France: Agence Fédérale des Médicaments et des Produits de Santé (AFSSAPS; Hungary: National Institute of Pharmacy; Austria: AGES-PharmMed LCM; Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS); Portugal:INFARMED - Instituto Nacional da Farmácia e do Medicamento Parque da Saúde de Lisboa; Greece: EOF - National Drug Organisation; Italy: Azienda Ospedaliera di Lecco

Study placed in the following topic categories:

Sevelamer
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Hyperphosphatemia
Chelating Agents
Kidney Diseases
Metabolic Disorder
Kidney Failure

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders
Renal Insufficiency
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Kidney Failure, Chronic
Hyperphosphatemia
Pharmacologic Actions

Sevelamer
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Chelating Agents
Kidney Failure

ClinicalTrials.gov processed this record on August 28, 2009