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COMPLETEDPHASE3

Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis

NCT00268957•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

Summary

Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•On three times per week hemodialysis for three months or longer
•Currently on a phosphate binder(s)
•Considered compliant with phosphate binders and hemodialysis therapy
•Willing to avoid any intentional changes in diet such as fasting or dieting
•Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
•Have the following central laboratory measurements: a.A serum phosphorus measurement \> 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening
•Have not participated in any other investigational drug studies within 30 days prior to enrollment
•Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
•Willing and able to take sevelamer alone as a phosphate binder for the duration of the study
•Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons
+4 more criteria

Exclusion Criteria

•Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders
•Active ethanol or drug abuse, excluding tobacco use
•In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
•Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
•Known hypersensitivity to sevelamer or any constituents of the study drug
•Pregnant or breast-feeding
•Evidence of active malignancy except for basal cell carcinoma of the skin
•Unable to comply with the requirements of the study
•Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study

Locations (29)

Clinical Research Center

Birmingham, Alabama, United States

Gadsden Dialysis

Gadsden, Alabama, United States

Holy Cross Renal Care

Mission Hills, California, United States

Nephrology Educational Services and Research

Tarzana, California, United States

Crystal Rivers Dialysis Center

Crystal River, Florida, United States

Outcomes Research International, Inc.

Hudson, Florida, United States

Central Dialysis Center

Atlanta, Georgia, United States

Atlanta Nephrology Referral Center

Decatur, Georgia, United States

FMC Marietta

Marietta, Georgia, United States

Horizon Healthcare Associates

Flossmoor, Illinois, United States

Key Dates

Start Date

January 1, 2006

Primary Completion Date

March 1, 2007

Completion Date

May 1, 2007

Last Updated

March 19, 2014

Enrollment

217

ACTUAL participants

Conditions

Kidney DiseasesChronic Renal InsufficiencyEnd-Stage Renal Disease

Interventions

Sevelamer carbonate (Renvela®)

DRUG

Sevelamer hydrochloride (Renagel®)

DRUG

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

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Kidney Disease, End-StageEnd-stage Renal Disease+1 more

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A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

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Peripheral Vascular DiseasesKidney Diseases

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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: March 19, 2014Data 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.

View ClinicalTrials.gov Terms and Conditions

Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

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