GD3-199-301: Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With Chronic Kidney Disease on Hemodialysis

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00268957

Purpose

Approximately 207 of 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. Total length of participation is approximately 24 weeks.

Condition	Intervention	Phase
Kidney Disease Chronic Renal Insufficiency End Stage Renal Disease	Drug: sevelamer carbonate, 2.4g	Phase III

Study Type: Interventional

Study Design: Treatment, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: 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.

Further Study Details:

Primary Outcomes: Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed 3x a day with meals on the control of serum phosphorus.; Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals.

Secondary Outcomes: Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile.

Expected Total Enrollment: 207

Study Start: 2006-01

Eligibility

Ages Eligible for Study: 18 Years - N/A, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Men or women 18 years of age or older

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:

Two most recent consecutive serum phosphorus measurements that are ≥3.0 and ≤6.5 (6.5) mg/dL within 60 days of screening

A most recent iPTH measurement ≤800 pg/mL within 90 days of screening

Have the following central laboratory measurements:

A serum phosphorus measurement > 5.5 mg/dL at randomization (Week 0)

A serum iPTH measurement ≤ 800 pg/mL at screening

Has 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

Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement

If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or IUDs

Life expectancy of 12 months or greater

Willing and able to provide informed consent

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

Location and Contact Information

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

Alabama
Gadsden Dialysis, Gadsden, Alabama, 35901, United States

Clinical Research Center, Birmingham, Alabama, 35213, United States

California
Nephrology Educational Services and Research, Encino, California, 91316, United States
Holy Cross Renal Care, Mission Hills, California 91345, United States

Florida
Crystal Rivers Dialysis Center, Crystal River, Florida, 34429, United States
Outcomes Research International, Inc., Hudson, Florida, 34667, United States

Georgia
FMC Marietta, Marietta, Georgia, 30066, United States
Central Dialysis Center, Atlanta, Georgia 30329, United States
Atlanta Nephrology Referral Center, Decatur, Georgia, 30030, United States

Illinois
Horizon Healthcare Associates, Flossmoor, Illinois, 60422, United States

Indiana
Indiana University Hospital, Indianapolis, Indiana, 46202, United States

Louisiana
Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States

Michigan
Henry Ford Hospital, Detroit, Michigan, 48202, United States

Mississippi
Nephrology Associates, P.C., Columbus, Mississippi, 39705, United States
Nephology & Hypertenstion Associate, LTD, Tupelo, Mississippi, 38801, United States
Southwest Mississippi Nephrology, PLLC, Brookhaven, Mississippi, 39601, United States

Missouri
Washington University School of Medicine, St. Louis, Missouri, 63110, United States

New Jersey
Hypertension and Nephrology Associates, Eatontown, New Jersey, 07724, United States

New York
Winthrop University Dialysis Center, Mineola, New York, 11501, United States
Davita, Bronx, New York, 10461, United States

Ohio
Kidney and Hypertension Center, Cincinnati, Ohio, 45220, United States
Renal Care Group, Cleveland, Ohio, 44109, United States

Pennsylvania
Lewiston Dialysis Center, Lewistown, Pennsylvania, 17044, United States

Tennessee
Nephrology Associates, P.C., Nashville, Tennessee, 37205, United States
Medical Nephrology Associates, Dyersburg, Tennessee, 38024, United States

Texas
Renal Research Inc. at the Kidney Institute, Houston, Texas, 77054, United States

Virginia
Clinical Research of Tidewater, Norfolk, Virginia, 23507, United States
Gambro Healthcare - Charlottesville, Charlottesville, Virginia, 22902, United States
Virginia Commonwealth University, Division of Nephrology, Richmond, Virginia, 23298, United States

More Information

Study ID Numbers GD3-199-301
NLM Identifier NCT00268957
Health Authority: United States: Food and Drug Administration